Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)

• Sponsor: EMD Serono Research & Development Institute, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01772004
• Collaborator: Merck KGaA, Darmstadt, Germany (Industry)
• Enrollment: 1,756
• Locations: 74
• Arms: 23
• Actual Duration (Months): 82.5
• Patients Per Site: 23.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: Escalation revised dosing regimen cohort.

Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: Avelumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 1756 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
• Actual Study Start Date: Jan 31, 2013
• Actual Primary Completion Date: Dec 16, 2019
• Actual Study Completion Date: Dec 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation Cohort: Avelumab 1.0 mg/kg Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Dose Escalation Cohort: Avelumab 3.0 mg/kg Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Dose Escalation Cohort: Avelumab 10.0 mg/kg Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Dose Escalation Cohort: Avelumab 20.0 mg/kg Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Primary Expansion Cohort: NSCLC, Post-platinum Doublet Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Primary Expansion Cohort: NSCLC, First Line Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Primary Expansion Cohort: Metastatic Breast Cancer Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Primary Expansion Cohort: GC/GEJC Progressed Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who progressed on or after first line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Primary Expansion Cohort: GC/GEJC Non Progressed Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Colorectal Cancer Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Castrate-resistant Prostate Cancer Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Adrenocortical Carcinoma Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Melanoma Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Mesothelioma Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Urothelial Carcinoma Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Ovarian Cancer Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Renal Cell Carcinoma (First Line) Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line) Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Efficacy Expansion Cohort: Ovarian Cancer Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Efficacy Expansion Cohort: Urothelial Carcinoma Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Efficacy Expansion Cohort: GC/ GEJC, Third Line Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1
Experimental: Efficacy Expansion Cohort: HNSCC Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Drug: Avelumab; Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.; Other Names: MSB0010718C Anti PD-L1

Outcome Measures

Primary Outcome Measures

1. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) [Dose Escalation: Baseline up to Week 3]

   DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) >=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resolves to <= Gr 1, Gr3 diarrhea, Gr 3 skin toxicity, Gr 3 liver function test increase that resolves to <= Gr1 in < 7 days after medical management has been initiated, Single laboratory values out of normal range that were unlikely related to study treatment according to investigator, did not have any clinical correlate, and resolved to <= Gr1 within 7 days with adequate medical management and tumor flare phenomenon defined as local pain, irritation/rash localized at sites of known/suspected tumor.

2. Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) [Ovarian Cancer Efficacy Expansion: Baseline up to Day 620]

   Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.

3. Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) [Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931]

   Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.

4. Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) [GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871]

   Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.

5. Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) [HNSCC Efficacy Expansion: Baseline up to Day 1072]

   Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.

Secondary Outcome Measures

1. Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity [Up to Day 2511]

   Adverse event(AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event(SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration.TEAEs included both Serious TEAEs and non-serious TEAEs. Severity of TEAEs were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.

2. Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity [Baseline up to Day 2511]

   AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.

3. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of Avelumab [Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion]

   Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.

4. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab [Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion]

   The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.

5. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab [Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion]

   Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.

6. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Time to Reach Maximum Observed Serum Concentration (Tmax) of Avelumab [Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion]

   Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.

7. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Apparent Terminal Half-Life (t1/2) of Avelumab [Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion]

   Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.

8. Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab [At Day 1, 15, 29, 43, 85, 127 and 169]

   Serum concentration at end of infusion (CEOI) of Avelumab is reported.

9. Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab [At Day 15, 29, 43, 57, 71, 85, 99, 127 and 169]

   Serum Ctrough concentration of Avelumab is reported.

10. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC) [Dose Escalation: Baseline up to Day 1023]

    irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.

11. Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC) [Dose Expansion: Baseline up to Day 2023]

    irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.

12. Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [Dose Escalation: Baseline up to Day 2511]

    BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD =Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

13. Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [Dose Expansion: Baseline up to Day 2023]

    BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD = Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.

14. Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee [Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931]

    Confirmed Best Overall Response (BOR) was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and as adjudicated by an Independent Endpoint Review Committee (IERC) is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with BOR in each category (CR, PR, SD, PD) were reported.

15. Dose Expansion Cohort: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [Dose Expansion: Baseline up to Day 2023]

    The PFS time (based on investigator assessments), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.

16. Dose Expansion Cohort: Immune Related Progression-Free Survival (irPFS) Time According to Modified Immune-Related Response Criteria (irRC) [Dose Expansion: Baseline up to Day 2023]

    The irPFS time was defined as the time from first administration of study treatment until first documentation of immune-related progressive disease (irPD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). irPD: sum of the longest diameters of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. The analysis of irPFS will be performed with a Kaplan-Meier method. Data for immune related progression-free survival time has been reported.

17. Dose Expansion Cohort: Overall Survival (OS) Time [Dose Expansion: Baseline up to Day 2023]

    Overall survival time was measured as time in months first administration of trial treatment to death. The analysis of OS time was performed with a Kaplan-Meier method.

18. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy [Pre-infusion on Day 1; 48 hours after infusion on Day 3; Pre-infusion on Days 15, 43, and 85]

    Percentage of PD-L1 receptors occupied by avelumab on human lymphocytes (CD3+ T-cells) was assessed by flow cytometry on peripheral blood mononuclear cell (PBMC) samples. Greater than or equal to [>=] 85 percent [%] of cell viability was required for reliable receptor occupancy assessment.

19. Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue [Dose Expansion: Baseline up to Day 2023]

    PD-L1 assessment was performed using immunohistochemistry. PD-L1 expression status was classified as positive or negative based on the following cut-offs: For tumor cells: Participants were considered PD-L1 expression positive (negative): - if at least (less than) 5% of the tumor cells show PD-L1 membrane staining >= 1+, respectively. This was used as the primary cut-off; - if at least (less than) 25% of the tumor cells show PD-L1 membrane staining >=2+, respectively. This was considered as secondary cut-off; - if at least (less than) 1% of the tumor cells show PD-L1 membrane staining >=1+, respectively. This was used as the tertiary cut-off; - if at least (less than) 50% of the tumor cells show PD-L1 membrane staining >=1+, respectively. This was used as the '50% cut-off'; - if at least (less than) 80% of the tumor cells show PD-L1 membrane staining ≥1+, respectively. This was used as the '80% cut-off'.

20. Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [Week 13]

    The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR and PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with unconfirmed response at week 13 according to response evaluation criteria in solid tumors (RECIST) version 1.1 were reported.

21. Dose Expansion Cohort: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Per Investigator Assessment [Dose Expansion: Baseline up to Day 2023]

    Duration of response according to RECIST 1.1, per investigator assessment was calculated for each participant with a confirmed response (complete response [CR] or partial response [PR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Results were calculated based on Kaplan-Meier estimates.

22. Dose Expansion Cohort: Duration of Response According to Modified Immune-Related Response Criteria (irRC) Per Investigator Assessment [Dose Expansion: Baseline up to Day 2023]

    Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response [irCR] or immune-related partial response [irPR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.

23. Efficacy Expansion Cohorts: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Per Independent Endpoint Review Committee (IERC) [Efficacy Expansion: Baseline up to Day 1072]

    Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response [irCR] or immune-related partial response [irPR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.

24. Efficacy Expansion Cohorts: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Per Independent Endpoint Review Committee (IERC) [Efficacy Expansion: Baseline up to Day 1072]

    The PFS time (based on IERC), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.

25. Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With at Least 1 Positive Anti Drug Antibodies (ADA) [Dose Escalation: Baseline up to Day 1023]

    Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.

26. Dose Expansion Cohort: Number of Participants With Atleast 1 Positive Anti Drug Antibodies (ADA) Assay [Dose Expansion: Baseline up to Day 2023]

    Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria for dose escalation and expansion phase:

• Signed written informed consent

• Male or female participants aged greater than or equal to 18 years

• Participants must have histologically or cytologically proven metastatic or locally advanced solid tumors, for which no standard therapy exists or standard therapy has failed. Availability of tumor archival material or fresh biopsies is optional for participants in dose escalation

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months

• Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST 1.1, except for participants with metastatic castrate-resistant prostate cancer (mCRPC) or metastatic breast cancer (MBC) who may be enrolled with objective evidence of disease without a measureable lesion

• Adequate hematological, hepatic and renal function as defined in the protocol

• Effective contraception for both male and female participants if the risk of conception exists

• Other protocol defined inclusion criteria could apply

Inclusion Criteria for expansion phase:

• Participants must have relapsed, refractory, or progressive disease following last line of treatment (with the exception of the gastric and gastroesophageal junction (GEJ) cancer cohort, which does not require progression). Availability of tumor archival material or fresh biopsies (excluding bone biopsies) is mandatory for eligibility in the expansion cohorts. For participants in the MBC cohort, the biopsy or surgical specimen must have been collected within 90 days prior to the first investigational medicinal product (IMP) administration. Specifically, the following will be required:

• NSCLC post platinum doublet: Histologically or cytologically confirmed stage IIIB or stage IV NSCLC that has progressed after 1 line of platinum-containing doublet chemotherapy. Participants should have received only 1 line of platinum-containing treatment for metastatic disease (i.e., adjuvant treatment with a platinum-containing regimen is not sufficient for eligibility because not received in the context of a metastatic disease). Participants in the NSCLC cohort will only be enrolled in USA

• NSCLC first line: Stage IV (per 7th International Association for the Study of Lung Cancer [IASLC] classification) or recurrent NSCLC that is histologically proven. Participants must not have received treatment for their metastatic or recurrent disease. No activating epidermal growth factor receptor (EGFR) mutation nor ALK translocation/re-arrangement

• Gastric and GEJ cancer: Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction, treated with first-line chemotherapy combination with or without disease progression. Participants should have received no more than 1 line of treatment for metastatic disease. Participants should not have been treated with trastuzumab (but can be Human Epidermal growth factor Receptor 2 [HER2] positive). Participants who received any platinum containing doublet or triplet as a neoadjuvant chemotherapy strategy, but are not ultimately candidates for surgery will also be eligible, as long as they did not have progressive disease after completion of the neoadjuvant chemotherapy. In addition, participants with gastric cancer can enter in the study if their white blood cell (WBC) and lymphocyte count is as defined in the protocol

• MBC: Participants must have histologically confirmed locally advanced or MBC and have tumor that is refractory to or progressive after standard of care therapy. Participants must have received no more than 3 prior lines of cytotoxic therapy for metastatic disease. Participants must have received a taxane and an anthracycline, unless contra-indicated

• Secondary expansion cohorts: Metastatic colorectal cancer (mCRC), Metastatic castrate-resistant prostate cancer (mCRPC), melanoma, ovarian cancer, ACC, mesothelioma, urothelial carcinoma and renal cell carcinoma as defined in the protocol

• Efficacy expansion cohorts: Gastric and GEJ cancer (third line), ovarian cancer (platinum Refractory + liposomal doxorubicin), urothelial carcinoma, and HNSCC as defined in the protocol

• Other protocol defined inclusion criteria for expansion phase could apply

Exclusion Criteria for dose escalation and expansion phase:

• Concurrent treatment with a non-permitted drug

• Prior therapy with specific antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)

• Concurrent anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of trial treatment; or concurrent systemic therapy with immunosuppressive agents, use of hormonal agents within 7 days before the start of trial treatment as defined in the protocol. Note: Participants receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab.

• Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ

• Rapidly progressive disease (for example, tumor lysis syndrome)

• Active or history of central nervous system metastases

• Receipt of any organ transplantation including allogeneic stem-cell transplantation

• Significant acute or chronic infections as defined in the protocol

• Active or history of any autoimmune disease (Participants with diabetes Type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies

• Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma

• Persisting toxicity related to prior therapy greater than Grade 1 NCI-CTCAE v4.0, however sensory neuropathy less than or equal to Grade 2 is acceptable

• Pregnancy or lactation period

• Known alcohol or drug abuse

• Clinically significant (that is, active) cardiovascular disease

• All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the Participant's tolerance of trial treatment

• Any psychiatric condition that would prohibit the understanding or rendering of informed consent

• Legal incapacity or limited legal capacity

• Non-oncology vaccine therapies for prevention of infection disease (for example, seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of study drug administration. Vaccination while on study is also prohibited except for administration of the inactivated influenza vaccine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Treatment Centers of America - Western Regional Medical Center	Goodyear	Arizona	United States	85338
2	Scottsdale Healthcare Corporation	Scottsdale	Arizona	United States	85258-4550
3	Pinnacle Oncology Hematology	Scottsdale	Arizona	United States	85258
4	Highlands Oncology Group	Rogers	Arkansas	United States	72758
5	Pacific Cancer Medical Center, Inc.	Anaheim	California	United States	92801
6	California Cancer Associates for Research & Excellence, Inc	Encinitas	California	United States	92024
7	Healing Hands Oncology and Medical Care	Inglewood	California	United States	90305
8	Scripps Health dba Scripps Clinical Research Services	La Jolla	California	United States	92037
9	The Angeles Clinic and Research Institute - West LA	Los Angeles	California	United States	90025
10	Cedars-Sinai Medical Center - Oncology	Los Angeles	California	United States	90048
11	University of California Davis Health System	Sacramento	California	United States	95817
12	Sharp Memorial Hospital	San Diego	California	United States	92123
13	Georgetown University Medical Center- Research Parent	Washington	District of Columbia	United States	20057
14	Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
15	University of Miami	Miami	Florida	United States	33136
16	Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast	Port Saint Lucie	Florida	United States	34952
17	Florida Cancer Specialists	Sarasota	Florida	United States	34232
18	Northeast Georgia Cancer Care, LLC	Athens	Georgia	United States	30607
19	Peachtree Hematology-Oncology Consultants, PC	Atlanta	Georgia	United States	30318
20	Augusta University - formerly Georgia Regents University	Augusta	Georgia	United States	30912
21	Northwest Georgia Oncology Centers PC	Marietta	Georgia	United States	30060
22	University of Chicago Medical Center	Chicago	Illinois	United States	60637
23	Horizon Oncology Research, INC	Lafayette	Indiana	United States	47905
24	The Johns Hopkins Hospital	Baltimore	Maryland	United States	21287-7049
25	RCCA MD LLC - Bethesda	Bethesda	Maryland	United States	20817
26	National Cancer Institute	Bethesda	Maryland	United States	20892
27	Maryland Oncology Hematology, P.A.	Rockville	Maryland	United States	20850
28	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
29	Henry Ford Medical Center	Detroit	Michigan	United States	48202
30	Michigan State University	Lansing	Michigan	United States	48910
31	Virginia Piper Cancer Institute	Minneapolis	Minnesota	United States	55407
32	Kansas City Research Institute, LLC - Phase I Unit	Kansas City	Missouri	United States	64131
33	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
34	San Juan Oncology Associates	Farmington	New Mexico	United States	87401
35	Montefiore Medical Center PRIME	Bronx	New York	United States	10461
36	Columbia University College of Phys & Surgeons	New York	New York	United States	10032
37	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27514
38	Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center	Huntersville	North Carolina	United States	28078
39	UC Health Clinical Trials Office	Cincinnati	Ohio	United States	45267-0502
40	University Hospitals Case Medical Center - Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106
41	OSU - James Comprehensive Cancer Center - Division of Hematology	Columbus	Ohio	United States	43210-1228
42	Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center - d/b/a The Mark H. Zangmeister Center	Columbus	Ohio	United States	43219
43	Oklahoma University Medical Center	Oklahoma City	Oklahoma	United States	73104
44	Penn State Univ. Milton S. Hershey Medical Center - MSHMC Cardiology	Hershey	Pennsylvania	United States	17033
45	Rhode Island Hospital	Providence	Rhode Island	United States	02903
46	Medical University of South Carolina	Charleston	South Carolina	United States	29245
47	The West Clinic	Germantown	Tennessee	United States	38138
48	Baptist Cancer Center	Memphis	Tennessee	United States	38120
49	SCRI - Tennessee Oncology	Nashville	Tennessee	United States	37203
50	Texas Oncology, P.A	Dallas	Texas	United States	75246
51	Oncology Consultants, P.A.	Houston	Texas	United States	77030
52	Texas Oncology, P.A. - Tyler	Tyler	Texas	United States	75702
53	Northwest Medical Specialties, PLLC	Lakewood	Washington	United States	98499-3071
54	GZA Ziekenhuizen - Campus Sint-Augustinus	Wilrijk		Belgium	2610
55	Nemocnice Rudolfa a Stefanie Benesov, a.s.	Benesov		Czechia	256 01
56	ICO - Site Paul Papin - service d'oncologie medicale	Angers cedex 2		France	49055
57	Centre Léon Bérard	Lyon		France	69008
58	Centre Antoine Lacassagne	Nice cedex 02		France	06189
59	Centre Paul Strauss - Service de Médecine Oncologique	Strasbourg Cedex		France	67000
60	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.	Mainz		Germany	55131
61	Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH - Innere Medizin II Haematologie / Onkologie	Villingen-Schwenningen		Germany	78052
62	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620
63	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
64	Seoul National University Hospital	Seoul		Korea, Republic of	03080
65	Severance Hospital, Yonsei University	Seoul		Korea, Republic of	03722
66	Asan Medical Center	Seoul		Korea, Republic of	05505
67	Gangnam Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	06273
68	Samsung Medical Center	Seoul		Korea, Republic of	06351
69	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
70	Centrum Onkologii-Instytut im. M. Sklodowskiej Curie - Dept of Digestive System Oncology	Warszawa		Poland	02-781
71	National Cheng Kung University Hospital	Tainan		Taiwan	704
72	National Taiwan University Hospital	Taipei		Taiwan	100
73	Sarah Cannon Research Institute UK	London		United Kingdom	W1G 6AD
74	Derriford Hospital - Dept of Oncology Clinical Trials	Plymouth		United Kingdom	PL6 8BQ

Sponsors and Collaborators

• EMD Serono Research & Development Institute, Inc.
• Merck KGaA, Darmstadt, Germany

Investigators

• Study Director: Medical Responsible, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Study Documents (Full-Text)

• Study Protocol - Aug 6, 2018
• Statistical Analysis Plan - Oct 12, 2015

More Information

Additional Information:

• Avelumab (anti-PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial

Publications

• Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL. Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study. J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.
• Gulley JL, Rajan A, Spigel DR, Iannotti N, Chandler J, Wong DJL, Leach J, Edenfield WJ, Wang D, Grote HJ, Heydebreck AV, Chin K, Cuillerot JM, Kelly K. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol. 2017 May;18(5):599-610. doi: 10.1016/S1470-2045(17)30240-1. Epub 2017 Mar 31.
• Heery CR, O'Sullivan-Coyne G, Madan RA, Cordes L, Rajan A, Rauckhorst M, Lamping E, Oyelakin I, Marté JL, Lepone LM, Donahue RN, Grenga I, Cuillerot JM, Neuteboom B, Heydebreck AV, Chin K, Schlom J, Gulley JL. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 2017 May;18(5):587-598. doi: 10.1016/S1470-2045(17)30239-5. Epub 2017 Mar 31.

• Responsible Party: EMD Serono Research & Development Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01772004
• Other Study ID Numbers: EMR 100070-001; 2013-002834-19
• First Posted: Jan 21, 2013
• Last Update Posted: Dec 20, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by EMD Serono Research & Development Institute, Inc.: Solid Tumors; MSB0010718C; Phase 1; Pharmacokinetic; anti PD-L1; Non-small cell lung cancer (NSCLC); Metastatic breast cancer (MBC); Gastric and gastroesophageal junction (GEJ) cancer; Ovarian cancer; Colorectal cancer (CRC); Castrate-resistant prostate cancer (CRPC); Melanoma; Urothelial carcinoma; Bladder cancer; Head and neck squamous cell carcinoma (HNSCC); Renal cell carcinoma (RCC); Adrenocortical carcinoma (ACC)
• Additional relevant MeSH terms: Neoplasms; Avelumab

Study Results

Participant Flow

Pre-assignment Detail	First participant signed informed consent: 31 January 2013, Last Participant Last Visit: 16 December 2019.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Period Title: Dose Escalation Phase
STARTED	4	13	15	21	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	4	13	15	21	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Dose Escalation Phase
STARTED	0	0	0	0	0	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
COMPLETED	0	0	0	0	0	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC	Total
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Total of all reporting groups
Overall Participants	4	13	15	21	8	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153	1756
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 75%	9 69.2%	10 66.7%	18 85.7%	5 62.5%	90 48.9%	51 32.7%	140 83.3%	38 63.3%	61 67.8%	19 90.5%	7 38.9%	46 92%	28 54.9%	20 37.7%	11 25%	74 59.2%	37 59.7%	7 35%	52 50.5%	66 32.2%	91 68.9%	97 63.4%	980 55.8%
>=65 years	1 25%	4 30.8%	5 33.3%	3 14.3%	3 37.5%	94 51.1%	105 67.3%	28 16.7%	22 36.7%	29 32.2%	2 9.5%	11 61.1%	4 8%	23 45.1%	33 62.3%	33 75%	51 40.8%	25 40.3%	13 65%	51 49.5%	139 67.8%	41 31.1%	56 36.6%	776 44.2%
Sex: Female, Male (Count of Participants)
Female	2 50%	9 69.2%	8 53.3%	7 33.3%	6 75%	84 45.7%	73 46.8%	167 99.4%	14 23.3%	22 24.4%	7 33.3%	0 0%	26 52%	17 33.3%	21 39.6%	14 31.8%	125 100%	19 30.6%	5 25%	103 100%	57 27.8%	47 35.6%	28 18.3%	861 49%
Male	2 50%	4 30.8%	7 46.7%	14 66.7%	2 25%	100 54.3%	83 53.2%	1 0.6%	46 76.7%	68 75.6%	14 66.7%	18 100%	24 48%	34 66.7%	32 60.4%	30 68.2%	0 0%	43 69.4%	15 75%	0 0%	148 72.2%	85 64.4%	125 81.7%	895 51%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2%	0 0%	0 0%	2 1.6%	0 0%	0 0%	0 0%	0 0%	2 1.5%	0 0%	5 0.3%
Asian	1 25%	0 0%	2 13.3%	0 0%	0 0%	5 2.7%	6 3.8%	3 1.8%	13 21.7%	35 38.9%	1 4.8%	0 0%	3 6%	2 3.9%	0 0%	2 4.5%	1 0.8%	6 9.7%	0 0%	7 6.8%	15 7.3%	42 31.8%	19 12.4%	163 9.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	2 1.1%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.3%	0 0%	0 0%	0 0%	0 0%	1 0.5%	0 0%	0 0%	4 0.2%
Black or African American	0 0%	0 0%	2 13.3%	0 0%	3 37.5%	12 6.5%	12 7.7%	16 9.5%	4 6.7%	4 4.4%	2 9.5%	4 22.2%	1 2%	1 2%	0 0%	2 4.5%	3 2.4%	1 1.6%	1 5%	4 3.9%	9 4.4%	6 4.5%	4 2.6%	91 5.2%
White	3 75%	13 100%	11 73.3%	20 95.2%	5 62.5%	159 86.4%	124 79.5%	141 83.9%	36 60%	44 48.9%	17 81%	12 66.7%	32 64%	35 68.6%	43 81.1%	35 79.5%	114 91.2%	35 56.5%	19 95%	91 88.3%	155 75.6%	70 53%	96 62.7%	1310 74.6%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	1 4.8%	0 0%	6 3.3%	14 9%	8 4.8%	7 11.7%	7 7.8%	1 4.8%	2 11.1%	14 28%	12 23.5%	10 18.9%	4 9.1%	5 4%	20 32.3%	0 0%	1 1%	25 12.2%	12 9.1%	34 22.2%	183 10.4%

Outcome Measures

1. Primary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Description	DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) >=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resolves to <= Gr 1, Gr3 diarrhea, Gr 3 skin toxicity, Gr 3 liver function test increase that resolves to <= Gr1 in < 7 days after medical management has been initiated, Single laboratory values out of normal range that were unlikely related to study treatment according to investigator, did not have any clinical correlate, and resolved to <= Gr1 within 7 days with adequate medical management and tumor flare phenomenon defined as local pain, irritation/rash localized at sites of known/suspected tumor.
Time Frame	Dose Escalation: Baseline up to Week 3

Outcome Measure Data

Analysis Population Description

DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants should have received all study drug administrations in the DLT evaluation period, or should have stopped treatment because of DLTs in the DLT evaluation period.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	3	3	6	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	1 4.8%

2. Primary Outcome

Title	Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
Time Frame	Ovarian Cancer Efficacy Expansion: Baseline up to Day 620

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Efficacy Expansion Cohort: Ovarian Cancer
Arm/Group Description	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	103
Complete response (CR)	3 75%
Partial response (PR)	1 25%
Stable disease (SD)	41 1025%
Progressive disease (PD)	39 975%
Non-CR/Non-PD	3 75%
Non-evaluable	16 400%

3. Primary Outcome

Title	Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Time Frame	Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Efficacy Expansion Cohort: Urothelial Carcinoma
Arm/Group Description	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	198
Complete response (CR)	6 150%
Partial response (PR)	26 650%
Stable disease (SD)	51 1275%
Progressive disease (PD)	77 1925%
Non-CR/Non-PD	1 25%
Non-evaluable	37 925%

4. Primary Outcome

Title	Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Time Frame	GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Efficacy Expansion Cohort: GC/GEJC, Third Line
Arm/Group Description	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	132
Complete response (CR)	2 50%
Partial response (PR)	5 125%
Stable disease (SD)	24 600%
Progressive disease (PD)	72 1800%
Non-CR/Non-PD	5 125%
Non-evaluable	24 600%

5. Primary Outcome

Title	Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)
Description	Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.
Time Frame	HNSCC Efficacy Expansion: Baseline up to Day 1072

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	153
Complete response (CR)	2 50%
Partial response (PR)	12 300%
Stable disease (SD)	46 1150%
Progressive disease (PD)	67 1675%
Non-CR/Non-PD	1 25%
Non-evaluable	25 625%

6. Secondary Outcome

Title	Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity
Description	Adverse event(AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event(SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration.TEAEs included both Serious TEAEs and non-serious TEAEs. Severity of TEAEs were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Time Frame	Up to Day 2511

Outcome Measure Data

Analysis Population Description

Safety analysis set (SAF) included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	13	15	21	8	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
Participants with TEAEs	4 100%	13 100%	15 100%	21 100%	8 100%	182 98.9%	156 100%	161 95.8%	60 100%	88 97.8%	21 100%	17 94.4%	50 100%	50 98%	53 100%	44 100%	122 97.6%	62 100%	19 95%	103 100%	204 99.5%	130 98.5%	149 97.4%
Participants with TEAEs with Grade 1 severity	0 0%	1 7.7%	1 6.7%	2 9.5%	2 25%	11 6%	3 1.9%	22 13.1%	5 8.3%	14 15.6%	2 9.5%	5 27.8%	1 2%	2 3.9%	2 3.8%	3 6.8%	11 8.8%	7 11.3%	1 5%	7 6.8%	15 7.3%	2 1.5%	14 9.2%
Participants with TEAEs with Grade 2 severity	0 0%	4 30.8%	4 26.7%	6 28.6%	3 37.5%	54 29.3%	45 28.8%	58 34.5%	9 15%	19 21.1%	9 42.9%	5 27.8%	10 20%	17 33.3%	21 39.6%	10 22.7%	52 41.6%	25 40.3%	5 25%	30 29.1%	46 22.4%	30 22.7%	43 28.1%
Participants with TEAEs with Grade 3 severity	2 50%	4 30.8%	6 40%	11 52.4%	3 37.5%	66 35.9%	68 43.6%	45 26.8%	29 48.3%	41 45.6%	6 28.6%	7 38.9%	25 50%	21 41.2%	23 43.4%	18 40.9%	42 33.6%	20 32.3%	10 50%	45 43.7%	82 40%	51 38.6%	54 35.3%
Participants with TEAEs with Grade 4 severity	0 0%	0 0%	2 13.3%	1 4.8%	0 0%	19 10.3%	15 9.6%	12 7.1%	7 11.7%	4 4.4%	1 4.8%	0 0%	8 16%	5 9.8%	3 5.7%	6 13.6%	3 2.4%	6 9.7%	1 5%	6 5.8%	16 7.8%	12 9.1%	12 7.8%
Participants with TEAEs with Grade 5 severity	2 50%	4 30.8%	2 13.3%	1 4.8%	0 0%	32 17.4%	25 16%	24 14.3%	10 16.7%	10 11.1%	3 14.3%	0 0%	6 12%	5 9.8%	4 7.5%	7 15.9%	14 11.2%	4 6.5%	2 10%	15 14.6%	45 22%	35 26.5%	25 16.3%
Participants with TEAEs with missing Grade	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.7%

7. Secondary Outcome

Title	Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity
Description	AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.
Time Frame	Baseline up to Day 2511

Outcome Measure Data

Analysis Population Description

SAF included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	13	15	21	8	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
Participants with Treatment-Related TEAEs	3 75%	9 69.2%	14 93.3%	17 81%	7 87.5%	146 79.3%	109 69.9%	118 70.2%	28 46.7%	57 63.3%	16 76.2%	15 83.3%	41 82%	39 76.5%	43 81.1%	32 72.7%	86 68.8%	51 82.3%	14 70%	65 63.1%	144 70.2%	71 53.8%	83 54.2%
Participants with Treatment-Related TEAEs with Grade 1 severity	1 25%	5 38.5%	7 46.7%	6 28.6%	2 25%	46 25%	29 18.6%	52 31%	14 23.3%	27 30%	4 19%	8 44.4%	12 24%	15 29.4%	8 15.1%	11 25%	46 36.8%	20 32.3%	4 20%	30 29.1%	50 24.4%	25 18.9%	39 25.5%
Participants with Treatment-Related TEAEs with Grade 2 severity	1 25%	4 30.8%	3 20%	8 38.1%	4 50%	71 38.6%	60 38.5%	46 27.4%	9 15%	22 24.4%	9 42.9%	6 33.3%	21 42%	20 39.2%	30 56.6%	18 40.9%	31 24.8%	23 37.1%	9 45%	26 25.2%	70 34.1%	33 25%	34 22.2%
Participants with Treatment-Related TEAEs with Grade 3 severity	1 25%	0 0%	3 20%	2 9.5%	1 12.5%	21 11.4%	17 10.9%	13 7.7%	4 6.7%	7 7.8%	3 14.3%	1 5.6%	8 16%	4 7.8%	3 5.7%	2 4.5%	7 5.6%	3 4.8%	1 5%	8 7.8%	20 9.8%	11 8.3%	9 5.9%
Participants with Treatment-Related TEAEs with Grade 4 severity	0 0%	0 0%	1 6.7%	1 4.8%	0 0%	8 4.3%	3 1.9%	5 3%	1 1.7%	0 0%	0 0%	0 0%	0 0%	0 0%	2 3.8%	1 2.3%	2 1.6%	5 8.1%	0 0%	1 1%	3 1.5%	1 0.8%	1 0.7%
Participants with Treatment-Related TEAEs with Grade 5 severity	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 1.2%	0 0%	1 1.1%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.5%	1 0.8%	0 0%
Participants with Treatment-Related TEAEs with missing Grade	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

8. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of Avelumab
Description	Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	13	15	21
Mean (Standard Deviation) [Hours*micrograms per milliliter]	1040 (443)	6080 (1970)	22749.4 (7857.09)	45100 (15600)

9. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab
Description	The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	2	12	13	15
Mean (Standard Deviation) [Hours*micrograms per milliliter]	1290 (650)	6850 (2100)	25920.9 (6753.76)	46600 (18500)

10. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab
Description	Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	13	15	21
Mean (Standard Deviation) [Micrograms per milliliter (mcg/mL)]	18.7 (3.96)	81.9 (22.1)	249.048 (55.4697)	489 (140)

11. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Time to Reach Maximum Observed Serum Concentration (Tmax) of Avelumab
Description	Tmax is time to reach maximum observed serum concentration obtained directly from the concentration versus time curve.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	13	15	21
Median (Full Range) [Hours]	1.500	1.500	1.500	1.717

12. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Apparent Terminal Half-Life (t1/2) of Avelumab
Description	Apparent terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination.
Time Frame	Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	2	12	13	15
Median (Full Range) [Hours]	61.425	89.064	97.440	108.671

13. Secondary Outcome

Title	Dose Expansion Phase: Serum Concentration at End of Infusion (CEOI) of Avelumab
Description	Serum concentration at end of infusion (CEOI) of Avelumab is reported.
Time Frame	At Day 1, 15, 29, 43, 85, 127 and 169

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data was reported for those arms for which end of infusion sample were collected as per planned analysis.

Arm/Group Title	Primary Expansion Cohort: NSCLC, First Line	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma (Second line) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer treated with a first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	117	18	13	16	85	84	29	124
Day 1	246 (87.4)	272 (73.9)	343 (117)	239 (50.2)	247 (77.3)	224 (55.4)	241 (75.0)	212 (47.6)
Day 15	297 (99.6)	305 (88.1)
Day 29	287 (89.5)	291 (60.3)
Day 43	250 (69.8)	306 (108)	294 (57.4)	255 (69.7)	268 (72.0)	241 (58.1)	240 (93.1)	249 (105)
Day 85	266 (79.5)	216 (24.9)	348 (65.6)	252 (78.9)	263 (66.4)	247 (66.4)	237 (5.54)	255 (57.7)
Day 127	269 (45.4)	339 (41.4)
Day 169	304 (64.9)	272	287	235	233 (90.4)	313 (59.3)	245 (51.7)

14. Secondary Outcome

Title	Dose Expansion Phase: Minimum Serum Post-dose (Ctrough) Concentration of Avelumab
Description	Serum Ctrough concentration of Avelumab is reported.
Time Frame	At Day 15, 29, 43, 57, 71, 85, 99, 127 and 169

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set was used. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluable at specified time points. Data for "primary expansion cohort: GC/GEJC Progressed" and "primary expansion cohort: GC/GEJC Non progressed" arms was reported as a single arm "primary expansion cohort: GC/GEJC Progressed/Non progressed" for this outcome measure as per planned analysis.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: GC/GEJC (Progressed/Non Progressed)	Primary Expansion Cohort: Metastatic Breast Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed/non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	163	124	129	154	32	17	13	45	48	57	17	43	118	21	117	87	82
Day 15	20.4 (16.1)	18.3 (10.3)	22.5 (11.1)	23.7 (24.6)	17.8 (9.51)	22.4 (14.1)	28.8 (14.5)	22.3 (13.4)	21.7 (26.7)	26.9 (14.4)	25.1 (11.6)	21.3 (12.0)	23.1 (14.1)	18.1 (12.4)	20.1 (10.1)	22.3 (11.1)	17.6 (10.7)
Day 29	23.5 (15.4)	23.5 (15.1)	25.6 (15.2)	26.5 (17.0)	17.3 (13.6)	25.5 (20.1)	31.6 (15.9)	23.8 (17.3)	20.7 (12.4)	35.7 (22.3)	27.4 (16.6)	26.2 (16.9)	27.7 (18.3)	18.6 (16.0)	27.0 (23.9)	23.9 (16.2)	21.3 (13.0)
Day 43	24.6 (15.6)	23.8 (15.9)	28.3 (18.2)	29.7 (17.8)	20.6 (14.3)	23.2 (24.2)	32.3 (16.3)	29.3 (22.9)	23.6 (18.9)	35.7 (22.6)	29.4 (19.7)	28.1 (18.9)	28.4 (20.9)	19.8 (21.5)	29.0 (17.6)	27.7 (18.1)	25.2 (17.7)
Day 57	26.2 (17.3)	23.4 (16.1)	26.5 (14.1)	28.9 (14.5)	22.2 (19.8)	29.9 (22.4)	18.2 (11.7)	39.8 (25.5)	25.5 (18.7)	29.7 (22.8)	27.3 (21.5)	16.2 (15.2)	30.6 (18.1)	28.5 (20.3)	24.1 (15.6)
Day 71	27.9 (36.5)	31.0 (40.1)	28.1 (16.6)	29.9 (15.4)	22.0 (15.5)	28.8 (23.6)	21.0 (14.2)	38.4 (33.4)	27.8 (17.6)	29.4 (22.1)	33.4 (31.8)	19.6 (15.3)	31.1 (18.8)	30.4 (23.0)	24.2 (14.7)
Day 85	27.8 (18.9)	27.7 (16.7)	29.7 (18.1)	28.9 (16.8)	24.9 (29.0)	8.03 (0.988)	37.9 (18.3)	35.6 (23.7)	23.7 (15.8)	39.7 (27.2)	34.4 (20.2)	34.7 (20.5)	39.1 (28.3)	19.3 (3.60)	35.6 (20.7)	31.2 (22.0)	28.0 (14.6)
Day 99	28.8 (13.6)
Day 127	36.9 (24.0)	39.1 (40.2)	33.1 (24.0)	28.8 (22.1)	34.2	44.2 (12.7)	58.6 (76.7)	25.9 (11.3)	35.7 (18.2)	40.7 (25.1)
Day 169	36.6 (25.8)	39.1 (19.8)	31.4 (18.2)	31.9 (14.0)	24.7 (28.1)	10.5	35.3 (20.2)	28.7 (11.4)	47.1 (26.8)	43.6	38.8 (19.2)	49.3 (27.3)	32.5 (14.7)	28.3 (20.0)	37.3 (31.6)

15. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Description	irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
Time Frame	Dose Escalation: Baseline up to Day 1023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	13	15	21
Immune-related Complete Response	0 0%	0 0%	0 0%	0 0%
Immune-related Partial Response	0 0%	0 0%	1 6.7%	1 4.8%
Immune-related Stable Disease	2 50%	8 61.5%	8 53.3%	14 66.7%
Immune-related Progressive Disease	0 0%	5 38.5%	4 26.7%	1 4.8%
Not Evaluable	2 50%	0 0%	2 13.3%	5 23.8%

16. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)
Description	irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Immune-related Complete Response	2 50%	4 30.8%	1 6.7%	0 0%	2 25%	0 0%	0 0%	0 0%	4 6.7%	1 1.1%	2 9.5%	1 5.6%	1 2%	0 0%	3 5.7%	10 22.7%	1 0.8%	6 9.7%
Immune-related Partial Response	26 650%	31 238.5%	6 40%	5 23.8%	4 50%	0 0%	0 0%	3 1.8%	7 11.7%	4 4.4%	5 23.8%	15 83.3%	10 20%	2 3.9%	4 7.5%	24 54.5%	7 5.6%	15 24.2%
Immune-related Stable Disease	80 2000%	78 600%	60 400%	20 95.2%	53 662.5%	9 4.9%	3 1.9%	26 15.5%	20 33.3%	31 34.4%	21 100%	61 338.9%	40 80%	15 29.4%	44 83%	61 138.6%	29 23.2%	61 98.4%
Immune-related Progressive Disease	36 900%	21 161.5%	69 460%	0 0%	0 0%	5 2.7%	1 0.6%	14 8.3%	11 18.3%	10 11.1%	10 47.6%	27 150%	6 12%	1 2%	33 62.3%	62 140.9%	62 49.6%	44 71%
Not Evaluable	40 1000%	22 169.2%	32 213.3%	35 166.7%	31 387.5%	7 3.8%	14 9%	7 4.2%	9 15%	7 7.8%	6 28.6%	21 116.7%	5 10%	2 3.9%	19 35.8%	41 93.2%	33 26.4%	27 43.5%

17. Secondary Outcome

Title	Dose Escalation Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description	BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD =Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame	Dose Escalation: Baseline up to Day 2511

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	13	15	21	8
Complete Response	0 0%	0 0%	0 0%	0 0%	0 0%
Partial Response	0 0%	0 0%	1 6.7%	1 4.8%	1 12.5%
Stable Disease	2 50%	8 61.5%	8 53.3%	14 66.7%	4 50%
Progressive Disease	0 0%	5 38.5%	4 26.7%	3 14.3%	1 12.5%
Not Evaluable	2 50%	0 0%	2 13.3%	3 14.3%	2 25%

18. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description	BOR was determined according to RECIST v1.1 and as per investigator assessment. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD = Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Complete Response	2 50%	3 23.1%	1 6.7%	0 0%	2 25%	0 0%	0 0%	0 0%	4 6.7%	1 1.1%	2 9.5%	1 5.6%	1 2%	0 0%	3 5.7%	7 15.9%	1 0.8%	5 8.1%
Partial Response	24 600%	28 215.4%	4 26.7%	4 19%	4 50%	0 0%	0 0%	3 1.8%	7 11.7%	4 4.4%	4 19%	11 61.1%	9 18%	2 3.9%	4 7.5%	24 54.5%	7 5.6%	15 24.2%
Stable Disease	66 1650%	68 523.1%	41 273.3%	13 61.9%	45 562.5%	9 4.9%	10 6.4%	21 12.5%	16 26.7%	26 28.9%	20 95.2%	53 294.4%	38 76%	13 25.5%	37 69.8%	45 102.3%	23 18.4%	50 80.6%
Progressive Disease	68 1700%	40 307.7%	107 713.3%	36 171.4%	29 362.5%	9 4.9%	5 3.2%	22 13.1%	17 28.3%	18 20%	14 66.7%	51 283.3%	11 22%	4 7.8%	46 86.8%	87 197.7%	80 64%	66 106.5%
Not Evaluable	24 600%	17 130.8%	15 100%	7 33.3%	10 125%	3 1.6%	3 1.9%	4 2.4%	7 11.7%	4 4.4%	4 19%	9 50%	3 6%	1 2%	13 24.5%	35 79.5%	21 16.8%	17 27.4%

19. Secondary Outcome

Title	Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
Description	Confirmed Best Overall Response (BOR) was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and as adjudicated by an Independent Endpoint Review Committee (IERC) is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with BOR in each category (CR, PR, SD, PD) were reported.
Time Frame	Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. This outcome measure was planned to be analyzed in Secondary Urothelial Carcinoma Cohort only.

Arm/Group Title	Secondary Expansion Cohort: Urothelial Carcinoma
Arm/Group Description	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	44
Complete Response	6 150%
Partial Response	1 25%
Stable Disease	16 400%
Non-CR/Non-PD	0 0%
Progressive Disease	16 400%
Not Evaluable	5 125%

20. Secondary Outcome

Title	Dose Expansion Cohort: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Description	The PFS time (based on investigator assessments), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Median (95% Confidence Interval) [Months]	2.66	4.04	1.35	1.38	2.76	1.41	5.39	2.56	3.06	4.11	2.69	2.60	8.28	5.55	1.45	1.41	1.31	1.77

21. Secondary Outcome

Title	Dose Expansion Cohort: Immune Related Progression-Free Survival (irPFS) Time According to Modified Immune-Related Response Criteria (irRC)
Description	The irPFS time was defined as the time from first administration of study treatment until first documentation of immune-related progressive disease (irPD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). irPD: sum of the longest diameters of target and new measurable lesions increases greater than or equal to [>=] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. The analysis of irPFS will be performed with a Kaplan-Meier method. Data for immune related progression-free survival time has been reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Median (95% Confidence Interval) [Months]	4.04	6.93	1.64	1.81	4.14	2.79	NA	3.81	6.83	6.18	4.07	4.04	8.34	6.90	2.60	2.46	1.35	2.83

22. Secondary Outcome

Title	Dose Expansion Cohort: Overall Survival (OS) Time
Description	Overall survival time was measured as time in months first administration of trial treatment to death. The analysis of OS time was performed with a Kaplan-Meier method.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	198	132	153
Median (95% Confidence Interval) [Months]	8.57	14.23	8.38	6.64	11.07	11.20	19.32	10.55	17.22	10.71	13.70	11.17	NA	16.85	9.13	6.97	3.35	7.98

23. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Programmed Death Ligand 1 (PD-L1) Receptor Occupancy
Description	Percentage of PD-L1 receptors occupied by avelumab on human lymphocytes (CD3+ T-cells) was assessed by flow cytometry on peripheral blood mononuclear cell (PBMC) samples. Greater than or equal to [>=] 85 percent [%] of cell viability was required for reliable receptor occupancy assessment.
Time Frame	Pre-infusion on Day 1; 48 hours after infusion on Day 3; Pre-infusion on Days 15, 43, and 85

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure and "number analyzed" signifies those who were evaluable for this outcome measure at specified time points.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	3	7	4	6
Day 1	0.0 (0.0)	0.0 (0.0)
Day 3	92.5 (1.99)	80.1 (14.43)	84.7 (12.83)
Day 15	75.7 (22.12)	90.0 (8.11)	93.2 (1.29)	85.0 (8.73)
Day 43	30.3	96.8
Day 85	19.8

24. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue
Description	PD-L1 assessment was performed using immunohistochemistry. PD-L1 expression status was classified as positive or negative based on the following cut-offs: For tumor cells: Participants were considered PD-L1 expression positive (negative): - if at least (less than) 5% of the tumor cells show PD-L1 membrane staining >= 1+, respectively. This was used as the primary cut-off; - if at least (less than) 25% of the tumor cells show PD-L1 membrane staining >=2+, respectively. This was considered as secondary cut-off; - if at least (less than) 1% of the tumor cells show PD-L1 membrane staining >=1+, respectively. This was used as the tertiary cut-off; - if at least (less than) 50% of the tumor cells show PD-L1 membrane staining >=1+, respectively. This was used as the '50% cut-off'; - if at least (less than) 80% of the tumor cells show PD-L1 membrane staining ≥1+, respectively. This was used as the '80% cut-off'.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "number analyzed" signifies those participants who were evaluable for this outcome measure at specified category.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	156	168	60	90	21	18	50	51	53	44	125	62	20	103	205	132	153
PD-L1 expression status - 1% cutoff	122 3050%	88 676.9%	87 580%	20 95.2%	26 325%	5 2.7%	0 0%	15 8.9%	19 31.7%	22 24.4%	14 66.7%	76 422.2%	20 40%	4 7.8%	45 84.9%	87 197.7%	39 31.2%	107 172.6%
PD-L1 expression status - 5% cutoff	84 2100%	76 584.6%	25 166.7%	1 4.8%	0 0%	12 6.5%	15 9.6%	16 9.5%	13 21.7%	32 35.6%	11 52.4%	1 5.6%	23 46%	72 141.2%	16 30.2%	93 211.4%
PD-L1 expression status - 25% cutoff	53 1325%	50 384.6%	3 20%	0 0%	0 0%	3 1.6%	7 4.5%	8 4.8%	5 8.3%	3 3.3%	2 9.5%	0 0%	6 12%	25 49%	6 11.3%	48 109.1%
PD-L1 expression status - 50% cutoff	54 1350%	53 407.7%	13 86.7%	1 4.8%	0 0%	5 2.7%	8 5.1%	5 3%	5 8.3%	2 2.2%	1 4.8%	0 0%	4 8%	34 66.7%	51 96.2%
PD-L1 expression status - 80% cutoff	41 1025%	38 292.3%	0 0%	2 9.5%	2 25%	2 1.1%	3 1.9%	2 1.2%	0 0%	0 0%	0 0%	25 138.9%	28 56%

25. Secondary Outcome

Title	Primary Expansion Cohorts: Number of Participants With Unconfirmed Response at Week 13 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description	The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR and PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with unconfirmed response at week 13 according to response evaluation criteria in solid tumors (RECIST) version 1.1 were reported.
Time Frame	Week 13

Outcome Measure Data

Analysis Population Description

Efficacy analysis set included all participants who have received at least 1 dose of study treatment and have measurable disease at baseline according to investigator assessment. This outcome measure was planned to be analyzed in Primary expansion cohorts only

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	156	168	60	90
Unconfirmed Complete Response	2 50%	1 7.7%	1 6.7%	0 0%	2 25%
Unconfirmed Partial Response	28 700%	24 184.6%	7 46.7%	6 28.6%	5 62.5%
Unconfirmed Stable Disease	62 1550%	54 415.4%	38 253.3%	11 52.4%	44 550%
Unconfirmed Progressive Disease	68 1700%	28 215.4%	107 713.3%	37 176.2%	31 387.5%
Non-evaluable	24 600%	49 376.9%	15 100%	6 28.6%	8 100%

26. Secondary Outcome

Title	Dose Expansion Cohort: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Per Investigator Assessment
Description	Duration of response according to RECIST 1.1, per investigator assessment was calculated for each participant with a confirmed response (complete response [CR] or partial response [PR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Results were calculated based on Kaplan-Meier estimates.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Data for this outcome measure is reported for the participants with Complete or Partial response.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	26	31	5	4	6	0	0	3	11	5	6	12	10	2	7	31	8	20
Median (95% Confidence Interval) [Months]	17.48	12.02	8.33	3.48	21.42	8.41	NA	15.21	NA	10.38	9.94	NA	NA	NA	NA	NA

27. Secondary Outcome

Title	Dose Expansion Cohort: Duration of Response According to Modified Immune-Related Response Criteria (irRC) Per Investigator Assessment
Description	Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response [irCR] or immune-related partial response [irPR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Data for this outcome measure is reported for the participants with Complete or Partial response.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	28	35	7	5	6	0	0	3	11	5	7	16	11	2	7	34	8	21
Median (95% Confidence Interval) [Months]	21.13	NA	8.31	4.14	22.23	NA	NA	15.21	NA	NA	10.61	NA	NA	NA	NA	NA

28. Secondary Outcome

Title	Efficacy Expansion Cohorts: Duration of Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Per Independent Endpoint Review Committee (IERC)
Description	Duration of response according to modified irRC, per investigator assessment was calculated for each participant with a confirmed response (immune-related complete response [irCR] or immune-related partial response [irPR]) as the time from the first observation of response to the first observation of documented disease progression (or death within 12 weeks of the last tumor assessment). irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). Results were calculated based on Kaplan-Meier estimates.
Time Frame	Efficacy Expansion: Baseline up to Day 1072

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.

Arm/Group Title	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	4	32	7	14
Median (95% Confidence Interval) [Months]	NA	NA	NA	NA

29. Secondary Outcome

Title	Efficacy Expansion Cohorts: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Per Independent Endpoint Review Committee (IERC)
Description	The PFS time (based on IERC), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first documentation of progressive disease (PD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. The analysis of PFS was performed with a Kaplan-Meier method.
Time Frame	Efficacy Expansion: Baseline up to Day 1072

Outcome Measure Data

Analysis Population Description

FAS included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed in Efficacy expansion cohorts only.

Arm/Group Title	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	103	198	132	153
Median (95% Confidence Interval) [Months]	1.87	1.45	1.31	1.41

30. Secondary Outcome

Title	Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants With at Least 1 Positive Anti Drug Antibodies (ADA)
Description	Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
Time Frame	Dose Escalation: Baseline up to Day 1023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg	Dose Escalation Cohort: Avelumab 3.0 mg/kg	Dose Escalation Cohort: Avelumab 10.0 mg/kg	Dose Escalation Cohort: Avelumab 20.0 mg/kg
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	3	13	9	20
Count of Participants [Participants]	0 0%	2 15.4%	0 0%	0 0%

31. Secondary Outcome

Title	Dose Expansion Cohort: Number of Participants With Atleast 1 Positive Anti Drug Antibodies (ADA) Assay
Description	Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
Time Frame	Dose Expansion: Baseline up to Day 2023

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Arm/Group Title	Primary Expansion Cohort: NSCLC, Post-platinum Doublet	Primary Expansion Cohort: NSCLC, First Line	Primary Expansion Cohort: Metastatic Breast Cancer	Primary Expansion Cohort: GC/GEJC Progressed	Primary Expansion Cohort: GC/GEJC Non Progressed	Secondary Expansion Cohort: Colorectal Cancer	Secondary Expansion Cohort: Castrate-resistant Prostate Cancer	Secondary Expansion Cohort: Adrenocortical Carcinoma	Secondary Expansion Cohort: Melanoma	Secondary Expansion Cohort: Mesothelioma	Secondary Expansion Cohort: Urothelial Carcinoma	Secondary Expansion Cohort: Ovarian Cancer	Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)	Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)	Efficacy Expansion Cohort: Ovarian Cancer	Efficacy Expansion Cohort: Urothelial Carcinoma	Efficacy Expansion Cohort: GC/GEJC, Third Line	Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.	Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Measure Participants	184	155	168	60	90	21	18	50	51	53	43	125	61	20	103	201	130	151
Count of Participants [Participants]	17 425%	9 69.2%	17 113.3%	3 14.3%	6 75%	0 0%	0 0%	4 2.4%	5 8.3%	3 3.3%	2 9.5%	5 27.8%	5 10%	3 5.9%	5 9.4%	17 38.6%	6 4.8%	5 8.1%

Adverse Events

Time Frame	Baseline up to Day 2511
Arm/Group Title	Dose Escalation Cohort: Avelumab 1.0 mg/kg		Dose Escalation Cohort: Avelumab 3.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg		Dose Escalation Cohort: Avelumab 20.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly		Primary Expansion Cohort: NSCLC, Post-platinum Doublet		Primary Expansion Cohort: NSCLC, First Line		Primary Expansion Cohort: Metastatic Breast Cancer		Primary Expansion Cohort: GC/GEJC Progressed		Primary Expansion Cohort: GC/GEJC Non Progressed		Secondary Expansion Cohort: Colorectal Cancer		Secondary Expansion Cohort: Castrate-resistant Prostate Cancer		Secondary Expansion Cohort: Adrenocortical Carcinoma		Secondary Expansion Cohort: Melanoma		Secondary Expansion Cohort: Mesothelioma		Secondary Expansion Cohort: Urothelial Carcinoma		Secondary Expansion Cohort: Ovarian Cancer		Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)		Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)		Efficacy Expansion Cohort: Ovarian Cancer		Efficacy Expansion Cohort: Urothelial Carcinoma		Efficacy Expansion Cohort: GC/GEJC, Third Line		Efficacy Expansion Cohort: HNSCC
Arm/Group Description	Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.		Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.		Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
All Cause Mortality
	Dose Escalation Cohort: Avelumab 1.0 mg/kg		Dose Escalation Cohort: Avelumab 3.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg		Dose Escalation Cohort: Avelumab 20.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly		Primary Expansion Cohort: NSCLC, Post-platinum Doublet		Primary Expansion Cohort: NSCLC, First Line		Primary Expansion Cohort: Metastatic Breast Cancer		Primary Expansion Cohort: GC/GEJC Progressed		Primary Expansion Cohort: GC/GEJC Non Progressed		Secondary Expansion Cohort: Colorectal Cancer		Secondary Expansion Cohort: Castrate-resistant Prostate Cancer		Secondary Expansion Cohort: Adrenocortical Carcinoma		Secondary Expansion Cohort: Melanoma		Secondary Expansion Cohort: Mesothelioma		Secondary Expansion Cohort: Urothelial Carcinoma		Secondary Expansion Cohort: Ovarian Cancer		Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)		Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)		Efficacy Expansion Cohort: Ovarian Cancer		Efficacy Expansion Cohort: Urothelial Carcinoma		Efficacy Expansion Cohort: GC/GEJC, Third Line		Efficacy Expansion Cohort: HNSCC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		11/13 (84.6%)		11/15 (73.3%)		16/21 (76.2%)		2/8 (25%)		161/184 (87.5%)		124/156 (79.5%)		141/168 (83.9%)		50/60 (83.3%)		75/90 (83.3%)		18/21 (85.7%)		7/18 (38.9%)		27/50 (54%)		25/51 (49%)		34/53 (64.2%)		31/44 (70.5%)		87/125 (69.6%)		17/62 (27.4%)		14/20 (70%)		71/103 (68.9%)		129/205 (62.9%)		118/132 (89.4%)		129/153 (84.3%)
Serious Adverse Events
	Dose Escalation Cohort: Avelumab 1.0 mg/kg		Dose Escalation Cohort: Avelumab 3.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg		Dose Escalation Cohort: Avelumab 20.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly		Primary Expansion Cohort: NSCLC, Post-platinum Doublet		Primary Expansion Cohort: NSCLC, First Line		Primary Expansion Cohort: Metastatic Breast Cancer		Primary Expansion Cohort: GC/GEJC Progressed		Primary Expansion Cohort: GC/GEJC Non Progressed		Secondary Expansion Cohort: Colorectal Cancer		Secondary Expansion Cohort: Castrate-resistant Prostate Cancer		Secondary Expansion Cohort: Adrenocortical Carcinoma		Secondary Expansion Cohort: Melanoma		Secondary Expansion Cohort: Mesothelioma		Secondary Expansion Cohort: Urothelial Carcinoma		Secondary Expansion Cohort: Ovarian Cancer		Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)		Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)		Efficacy Expansion Cohort: Ovarian Cancer		Efficacy Expansion Cohort: Urothelial Carcinoma		Efficacy Expansion Cohort: GC/GEJC, Third Line		Efficacy Expansion Cohort: HNSCC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/4 (75%)		6/13 (46.2%)		6/15 (40%)		8/21 (38.1%)		0/8 (0%)		95/184 (51.6%)		80/156 (51.3%)		66/168 (39.3%)		36/60 (60%)		44/90 (48.9%)		8/21 (38.1%)		2/18 (11.1%)		32/50 (64%)		24/51 (47.1%)		22/53 (41.5%)		19/44 (43.2%)		42/125 (33.6%)		14/62 (22.6%)		7/20 (35%)		48/103 (46.6%)		114/205 (55.6%)		87/132 (65.9%)		73/153 (47.7%)
Blood and lymphatic system disorders
Anaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		3/168 (1.8%)		3/60 (5%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		2/132 (1.5%)		1/153 (0.7%)
Autoimmune neutropenia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood loss anaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pancytopenia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Coagulopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thrombocytopenia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Leukocytosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thrombotic microangiopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cardiac disorders
Cardiac failure congestive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Acute coronary syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Atrial fibrillation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		2/168 (1.2%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		2/51 (3.9%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Cardiac tamponade	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Myocardial infarction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		4/156 (2.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pericardial effusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tachycardia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Cardiac arrest	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Cardiac failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cardio-respiratory arrest	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sinus tachycardia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Intracardiac thrombus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cardiac failure chronic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pericarditis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Acute myocardial infarction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Atrioventricular block	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ventricular fibrillation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Atrial flutter	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Bradycardia	0/4 (0%)		0/13 (0%)		0/15 (0%)		2/21 (9.5%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Myocarditis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Ear and labyrinth disorders
Vertigo positional	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Endocrine disorders
Adrenal insufficiency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Hypercalcaemia of malignancy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypothyroidism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Adrenocortical insufficiency acute	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thyroiditis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperthyroidism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Thyroiditis acute	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Eye disorders
Ocular retrobulbar haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Retinopathy hypertensive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vision blurred	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Visual impairment	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Eye pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Gastrointestinal disorders
Abdominal pain	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		2/168 (1.2%)		6/60 (10%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		4/50 (8%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		3/125 (2.4%)		0/62 (0%)		0/20 (0%)		6/103 (5.8%)		5/205 (2.4%)		8/132 (6.1%)		1/153 (0.7%)
Abdominal pain lower	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Ascites	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		3/60 (5%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		3/125 (2.4%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		0/205 (0%)		4/132 (3%)		0/153 (0%)
Constipation	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		4/125 (3.2%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		3/132 (2.3%)		0/153 (0%)
Duodenal obstruction	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Large intestinal obstruction	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nausea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		2/125 (1.6%)		0/62 (0%)		1/20 (5%)		4/103 (3.9%)		1/205 (0.5%)		7/132 (5.3%)		2/153 (1.3%)
Vomiting	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		2/51 (3.9%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		1/20 (5%)		6/103 (5.8%)		1/205 (0.5%)		7/132 (5.3%)		2/153 (1.3%)
Abdominal pain upper	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Incarcerated inguinal hernia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Large intestine perforation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Malignant gastrointestinal obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Colitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Ileal perforation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Inflammatory bowel disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Abdominal discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Abdominal distension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ileus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Obstruction gastric	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		4/132 (3%)		0/153 (0%)
Small intestinal obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		3/90 (3.3%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		6/125 (4.8%)		0/62 (0%)		0/20 (0%)		5/103 (4.9%)		4/205 (2%)		0/132 (0%)		0/153 (0%)
Haematemesis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Intestinal obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		3/125 (2.4%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Melaena	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Oesophageal stenosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Diarrhoea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		3/50 (6%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		2/103 (1.9%)		4/205 (2%)		0/132 (0%)		1/153 (0.7%)
Dyspepsia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		3/153 (2%)
Subileus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dysphagia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		3/60 (5%)		5/90 (5.6%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		3/153 (2%)
Oesophagitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peritoneal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rectal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Small intestinal perforation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haemorrhoids	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oesophagitis ulcerative	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Haematochezia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Intestinal perforation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pancreatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pancreatitis acute	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Abdominal wall haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Impaired gastric emptying	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Oesophageal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Oesophageal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Upper gastrointestinal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Gastric haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Mouth haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Strangulated umbilical hernia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tongue haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tongue oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
General disorders
Disease progression	0/4 (0%)		4/13 (30.8%)		2/15 (13.3%)		0/21 (0%)		0/8 (0%)		23/184 (12.5%)		16/156 (10.3%)		14/168 (8.3%)		8/60 (13.3%)		10/90 (11.1%)		3/21 (14.3%)		0/18 (0%)		6/50 (12%)		3/51 (5.9%)		3/53 (5.7%)		8/44 (18.2%)		13/125 (10.4%)		1/62 (1.6%)		2/20 (10%)		9/103 (8.7%)		34/205 (16.6%)		31/132 (23.5%)		18/153 (11.8%)
Fatigue	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Influenza like illness	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Non-cardiac chest pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		4/168 (2.4%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		3/53 (5.7%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Pyrexia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		3/51 (5.9%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		4/205 (2%)		1/132 (0.8%)		4/153 (2.6%)
Pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Systemic inflammatory response syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Asthenia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		3/156 (1.9%)		3/168 (1.8%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		2/51 (3.9%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		2/132 (1.5%)		0/153 (0%)
Chest pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Death	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
General physical health deterioration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		1/132 (0.8%)		1/153 (0.7%)
Medical device site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oedema due to cardiac disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gait disturbance	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chills	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oedema peripheral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Generalised oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Localised oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperthermia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Complication associated with device	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hepatobiliary disorders
Cholecystitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cholelithiasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Autoimmune hepatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Acute hepatic failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bile duct obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cholestasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatic failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cholangitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Liver injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hepatocellular injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Hyperbilirubinaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bile duct stenosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Drug-induced liver injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hepatic function abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cholecystitis acute	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Immune system disorders
Autoimmune disorder	0/4 (0%)		0/13 (0%)		2/15 (13.3%)		1/21 (4.8%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Anaphylactic reaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Type I hypersensitivity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sarcoidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infections and infestations
Pneumonia	1/4 (25%)		1/13 (7.7%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		12/184 (6.5%)		14/156 (9%)		2/168 (1.2%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		1/44 (2.3%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		4/205 (2%)		4/132 (3%)		3/153 (2%)
Kidney infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peritonitis bacterial	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Urinary tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		7/205 (3.4%)		0/132 (0%)		0/153 (0%)
Sepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		1/168 (0.6%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		5/205 (2.4%)		2/132 (1.5%)		5/153 (3.3%)
Bronchitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		3/156 (1.9%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Cystitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Septic shock	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urosepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		5/205 (2.4%)		0/132 (0%)		1/153 (0.7%)
Appendicitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Aspergillus infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bacterial sepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cellulitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		2/153 (1.3%)
Lung infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		2/153 (1.3%)
Pulmonary sepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Respiratory tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Upper respiratory tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Arteritis infective	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatitis E	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infected bite	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oral candidiasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Paronychia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peritonsillar abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Escherichia bacteraemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastroenteritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Lower respiratory tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Viral infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Clostridial sepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Device related infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Spinal cord infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bacteraemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Gastroenteritis viral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Perirectal abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Wound infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Pneumonia respiratory syncytial viral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gallbladder abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pneumonia bacterial	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pyelonephritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Rhinovirus infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urinary tract infection enterococcal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Clostridium difficile colitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Clostridium difficile infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Cystitis klebsiella	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Diverticulitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Klebsiella bacteraemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Postoperative wound infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Psoas abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Sepsis syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Staphylococcal bacteraemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urinary tract infection bacterial	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urinary tract infection fungal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Viral upper respiratory tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Herpes zoster	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
H1N1 influenza	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Peritonitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Systemic infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Injury, poisoning and procedural complications
Infusion related reaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		4/156 (2.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		4/205 (2%)		0/132 (0%)		1/153 (0.7%)
Hip fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Post-traumatic pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiation necrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiation pneumonitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Subdural haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thoracic vertebral fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cervical vertebral fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Femoral neck fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Femur fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrostomy tube site complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Humerus fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Spinal compression fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vascular access complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Wound complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Procedural complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Subarachnoid haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Upper limb fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lumbar vertebral fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Overdose	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Post procedural complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Fall	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Perirenal haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lower limb fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastroenteritis radiation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rib fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Accidental overdose	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Incorrect dose administered	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Post procedural haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tibia fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tracheal obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Investigations
Blood alkaline phosphatase increased	1/4 (25%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Alanine aminotransferase increased	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Amylase increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Aspartate aminotransferase increased	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Electrocardiogram T wave abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood potassium increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
False positive investigation result	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gamma-glutamyltransferase increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Neutrophil count decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Weight decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Transaminases increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Blood bilirubin increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Lipase increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Liver function test increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
General physical condition abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Inflammatory marker increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood creatine phosphokinase increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Electrocardiogram abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood creatine increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
C-reactive protein increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hepatic enzyme increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		2/132 (1.5%)		0/153 (0%)
Hypokalaemia	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hyponatraemia	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		2/205 (1%)		3/132 (2.3%)		1/153 (0.7%)
Hypercalcaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		2/153 (1.3%)
Dehydration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		4/50 (8%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		1/20 (5%)		3/103 (2.9%)		5/205 (2.4%)		3/132 (2.3%)		0/153 (0%)
Hyperkalaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		2/132 (1.5%)		0/153 (0%)
Hypovolaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Failure to thrive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperglycaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hypocalcaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hypoglycaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Type 1 diabetes mellitus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperuricaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Type 2 diabetes mellitus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metabolic acidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Malnutrition	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hypophosphataemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Musculoskeletal and connective tissue disorders
Myositis	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Musculoskeletal chest pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Musculoskeletal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Back pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		4/168 (2.4%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		4/205 (2%)		1/132 (0.8%)		0/153 (0%)
Bone pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pain in extremity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pathological fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Arthralgia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Muscular weakness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Groin pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Flank pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Myalgia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Spinal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Osteonecrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pain in jaw	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Chronic myeloid leukaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Malignant melanoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tumour pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		2/153 (1.3%)
Metastases to spine	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Non-small cell lung cancer metastatic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastases to meninges	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cancer pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Metastases to peripheral nervous system	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Myelodysplastic syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Neoplasm progression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Laryngeal cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Malignant pleural effusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Tumour invasion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tumour compression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastases to bone	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Metastases to ovary	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Leukaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Malignant ascites	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastases to liver	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Metastases to peritoneum	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Tumour associated fever	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Metastatic gastric cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Tumour haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		4/153 (2.6%)
Tonsil cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Gastric cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Nervous system disorders
Seizure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Embolic stroke	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Encephalopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haemorrhage intracranial	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Headache	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Hemiparesis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Monoplegia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Serotonin syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Syncope	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Thecal sac compression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cerebrovascular accident	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Spinal cord compression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Vocal cord paralysis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Ataxia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cerebral infarction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatic encephalopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Paraparesis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypoaesthesia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lethargy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Transient ischaemic attack	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Brain injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Posterior reversible encephalopathy syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sensorimotor disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dizziness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Neuropathy peripheral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ischaemic stroke	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Carotid artery stenosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Guillain-Barre syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Peripheral motor neuropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Depressed level of consciousness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Partial seizures	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Epilepsy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Neurotoxicity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Coma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Product Issues
Device dislocation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Device malfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Psychiatric disorders
Mental status changes	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hallucination	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Suicide attempt	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Confusional state	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Mood altered	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Completed suicide	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Delirium	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Renal and urinary disorders
Acute kidney injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		1/21 (4.8%)		0/18 (0%)		4/50 (8%)		1/51 (2%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		7/205 (3.4%)		5/132 (3.8%)		0/153 (0%)
Haematuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		7/205 (3.4%)		0/132 (0%)		0/153 (0%)
Nephrotic syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urinary tract obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Renal disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Renal failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bladder spasm	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hydronephrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Dysuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Haemorrhage urinary tract	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Ureteric obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urinary incontinence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Nephrolithiasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Renal ischaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Reproductive system and breast disorders
Pelvic pain	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)	0	0/21 (0%)	0	0/18 (0%)	0	0/50 (0%)	0	0/51 (0%)	0	0/53 (0%)	0	1/44 (2.3%)	0	0/125 (0%)	0	0/62 (0%)	0	0/20 (0%)	0	0/103 (0%)	0	1/205 (0.5%)	0	0/132 (0%)	0	0/153 (0%)	0
Postmenopausal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vaginal fistula	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		9/184 (4.9%)		5/156 (3.2%)		8/168 (4.8%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		4/53 (7.5%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		2/20 (10%)		3/103 (2.9%)		2/205 (1%)		3/132 (2.3%)		4/153 (2.6%)
Dysphonia	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypoxia	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		3/156 (1.9%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Pleural effusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		10/168 (6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		4/125 (3.2%)		0/62 (0%)		2/20 (10%)		6/103 (5.8%)		2/205 (1%)		3/132 (2.3%)		3/153 (2%)
Respiratory failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		3/184 (1.6%)		6/156 (3.8%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		3/103 (2.9%)		2/205 (1%)		3/132 (2.3%)		2/153 (1.3%)
Chronic obstructive pulmonary disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		7/184 (3.8%)		4/156 (2.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Acute respiratory failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		3/156 (1.9%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Haemoptysis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		3/153 (2%)
Dyspnoea exertional	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Respiratory distress	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Aspiration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Interstitial lung disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pneumonitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		2/168 (1.2%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		2/132 (1.5%)		0/153 (0%)
Pneumothorax	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pneumothorax spontaneous	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary embolism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		1/125 (0.8%)		1/62 (1.6%)		1/20 (5%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Acute respiratory distress syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chylothorax	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cough	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pneumonia aspiration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		5/153 (3.3%)
Respiratory acidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pleural fistula	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pleuritic pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Pulmonary arterial hypertension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary hypertension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bronchial obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bronchopneumopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Respiratory depression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lung infiltration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Respiratory arrest	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Epistaxis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Dyspnoea at rest	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Laryngeal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Pharyngeal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Skin and subcutaneous tissue disorders
Rash generalised	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rash maculo-papular	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Psoriasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Vascular disorders
Embolism	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypotension	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		3/205 (1.5%)		3/132 (2.3%)		0/153 (0%)
Jugular vein thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peripheral arterial occlusive disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peripheral artery thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peripheral ischaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Deep vein thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Subclavian vein thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ischaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypertension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Peripheral embolism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Orthostatic hypotension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Flushing	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lymphoedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Phlebitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Shock haemorrhagic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Intermittent claudication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Other (Not Including Serious) Adverse Events
	Dose Escalation Cohort: Avelumab 1.0 mg/kg		Dose Escalation Cohort: Avelumab 3.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg		Dose Escalation Cohort: Avelumab 20.0 mg/kg		Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly		Primary Expansion Cohort: NSCLC, Post-platinum Doublet		Primary Expansion Cohort: NSCLC, First Line		Primary Expansion Cohort: Metastatic Breast Cancer		Primary Expansion Cohort: GC/GEJC Progressed		Primary Expansion Cohort: GC/GEJC Non Progressed		Secondary Expansion Cohort: Colorectal Cancer		Secondary Expansion Cohort: Castrate-resistant Prostate Cancer		Secondary Expansion Cohort: Adrenocortical Carcinoma		Secondary Expansion Cohort: Melanoma		Secondary Expansion Cohort: Mesothelioma		Secondary Expansion Cohort: Urothelial Carcinoma		Secondary Expansion Cohort: Ovarian Cancer		Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)		Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)		Efficacy Expansion Cohort: Ovarian Cancer		Efficacy Expansion Cohort: Urothelial Carcinoma		Efficacy Expansion Cohort: GC/GEJC, Third Line		Efficacy Expansion Cohort: HNSCC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		13/13 (100%)		15/15 (100%)		21/21 (100%)		8/8 (100%)		178/184 (96.7%)		152/156 (97.4%)		159/168 (94.6%)		58/60 (96.7%)		86/90 (95.6%)		20/21 (95.2%)		17/18 (94.4%)		50/50 (100%)		50/51 (98%)		53/53 (100%)		44/44 (100%)		122/125 (97.6%)		62/62 (100%)		19/20 (95%)		102/103 (99%)		202/205 (98.5%)		125/132 (94.7%)		143/153 (93.5%)
Blood and lymphatic system disorders
Anaemia	2/4 (50%)		4/13 (30.8%)		6/15 (40%)		3/21 (14.3%)		1/8 (12.5%)		28/184 (15.2%)		22/156 (14.1%)		18/168 (10.7%)		12/60 (20%)		13/90 (14.4%)		5/21 (23.8%)		2/18 (11.1%)		16/50 (32%)		7/51 (13.7%)		12/53 (22.6%)		12/44 (27.3%)		9/125 (7.2%)		4/62 (6.5%)		3/20 (15%)		11/103 (10.7%)		36/205 (17.6%)		30/132 (22.7%)		25/153 (16.3%)
Lymphopenia	2/4 (50%)		3/13 (23.1%)		2/15 (13.3%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		3/51 (5.9%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		2/132 (1.5%)		5/153 (3.3%)
Thrombocytopenia	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		2/132 (1.5%)		1/153 (0.7%)
Iron deficiency anaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		9/184 (4.9%)		4/156 (2.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		3/51 (5.9%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		1/62 (1.6%)		1/20 (5%)		1/103 (1%)		3/205 (1.5%)		2/132 (1.5%)		1/153 (0.7%)
Leukocytosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		1/156 (0.6%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		2/205 (1%)		1/132 (0.8%)		5/153 (3.3%)
Lymph node pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Neutropenia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Hypothrombinaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lymphadenopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Pancytopenia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Splenic infarction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thrombocytosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Increased tendency to bruise	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Microcytic anaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lymphatic disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Leukopenia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Anaemia of chronic disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperchromasia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lymphadenitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Immune thrombocytopenic purpura	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Neutrophilia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Platelet dysfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Thrombocytopenic purpura	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Haemorrhagic anaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Cardiac disorders
Tachycardia	1/4 (25%)		0/13 (0%)		0/15 (0%)		2/21 (9.5%)		0/8 (0%)		5/184 (2.7%)		8/156 (5.1%)		5/168 (3%)		0/60 (0%)		2/90 (2.2%)		2/21 (9.5%)		1/18 (5.6%)		3/50 (6%)		1/51 (2%)		1/53 (1.9%)		1/44 (2.3%)		3/125 (2.4%)		1/62 (1.6%)		1/20 (5%)		6/103 (5.8%)		3/205 (1.5%)		2/132 (1.5%)		2/153 (1.3%)
Ventricular extrasystoles	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Sinus tachycardia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		7/184 (3.8%)		2/156 (1.3%)		2/168 (1.2%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		4/50 (8%)		0/51 (0%)		3/53 (5.7%)		2/44 (4.5%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		3/205 (1.5%)		2/132 (1.5%)		2/153 (1.3%)
Atrial fibrillation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		3/156 (1.9%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Palpitations	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		6/156 (3.8%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Sinus bradycardia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Angina pectoris	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pericardial effusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		3/168 (1.8%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		2/153 (1.3%)
Acute left ventricular failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Atrial flutter	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cardiac failure congestive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Cardiomyopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cyanosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Diastolic dysfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sinus arrhythmia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Supraventricular tachycardia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Tricuspid valve incompetence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cardiac failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Atrial tachycardia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Atrioventricular block first degree	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Atrioventricular block second degree	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bundle branch block	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Left atrial enlargement	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pericarditis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Right atrial enlargement	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Left ventricular failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Acute coronary syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Coronary artery disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nodal arrhythmia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Conduction disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Arrhythmia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Cardiomegaly	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cardiac tamponade	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Stress cardiomyopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Coronary artery stenosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Acute myocardial infarction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Bundle branch block right	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Heart valve incompetence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Mitral valve incompetence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Myocardial ischaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Atrial thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Bundle branch block left	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Cardiac failure chronic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Bradycardia	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Congenital, familial and genetic disorders
Hydrocele	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vertebral artery hypoplasia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Ear and labyrinth disorders
Ear discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Ear pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		3/156 (1.9%)		4/168 (2.4%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		6/153 (3.9%)
Ear congestion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tinnitus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		4/205 (2%)		0/132 (0%)		2/153 (1.3%)
Vertigo	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		5/156 (3.2%)		2/168 (1.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		3/153 (2%)
Vertigo positional	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Deafness unilateral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		2/153 (1.3%)
External ear inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Middle ear inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ear pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eustachian tube dysfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypoacusis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
External ear pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cerumen impaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Deafness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ear swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Otorrhoea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Endocrine disorders
Hypothyroidism	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		3/8 (37.5%)		16/184 (8.7%)		16/156 (10.3%)		12/168 (7.1%)		2/60 (3.3%)		3/90 (3.3%)		1/21 (4.8%)		3/18 (16.7%)		11/50 (22%)		3/51 (5.9%)		4/53 (7.5%)		3/44 (6.8%)		11/125 (8.8%)		7/62 (11.3%)		1/20 (5%)		5/103 (4.9%)		7/205 (3.4%)		5/132 (3.8%)		14/153 (9.2%)
Hyperthyroidism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		4/184 (2.2%)		5/156 (3.2%)		1/168 (0.6%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		3/62 (4.8%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		2/132 (1.5%)		0/153 (0%)
Adrenal insufficiency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Autoimmune thyroiditis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypopituitarism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Goitre	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypogonadism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Autoimmune hypothyroidism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thyroiditis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Adrenal mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cushing's syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Cushingoid	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Diabetes insipidus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperparathyroidism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperparathyroidism primary	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thyroid mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hypercalcaemia of malignancy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Eye disorders
Lacrimation increased	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Dry eye	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		2/168 (1.2%)		0/60 (0%)		5/90 (5.6%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		2/125 (1.6%)		2/62 (3.2%)		0/20 (0%)		4/103 (3.9%)		2/205 (1%)		0/132 (0%)		2/153 (1.3%)
Ocular hyperaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vision blurred	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		6/184 (3.3%)		4/156 (2.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		1/44 (2.3%)		6/125 (4.8%)		2/62 (3.2%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		2/132 (1.5%)		3/153 (2%)
Visual impairment	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		2/153 (1.3%)
Diplopia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Cataract	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Periorbital oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Blindness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cataract nuclear	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chorioretinal scar	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Conjunctival oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dermatochalasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eye discharge	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eye swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eyelid ptosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Glaucoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Iritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Periorbital swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Pinguecula	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vitreous floaters	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Eye irritation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Asthenopia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ocular discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Meibomian gland dysfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eye pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		4/153 (2.6%)
Episcleritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Conjunctival haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blindness unilateral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Eyelid oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Visual acuity reduced	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blepharitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chalazion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Conjunctivitis allergic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Retinal drusen	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Uveitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Anterior segment ischaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Keratitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Optic neuropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Periorbital pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Photophobia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Diabetic retinopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eyelid skin dryness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Scleral hyperaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Swelling of eyelid	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blepharospasm	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Erythema of eyelid	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Macular degeneration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Conjunctival deposit	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Eye pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Photopsia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Charles Bonnet syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Dry age-related macular degeneration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Ectropion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Exophthalmos	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Noninfective conjunctivitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Gastrointestinal disorders
Nausea	1/4 (25%)		2/13 (15.4%)		6/15 (40%)		2/21 (9.5%)		1/8 (12.5%)		55/184 (29.9%)		47/156 (30.1%)		50/168 (29.8%)		18/60 (30%)		20/90 (22.2%)		6/21 (28.6%)		2/18 (11.1%)		21/50 (42%)		10/51 (19.6%)		12/53 (22.6%)		12/44 (27.3%)		31/125 (24.8%)		20/62 (32.3%)		4/20 (20%)		33/103 (32%)		56/205 (27.3%)		31/132 (23.5%)		29/153 (19%)
Abdominal pain	1/4 (25%)		2/13 (15.4%)		2/15 (13.3%)		2/21 (9.5%)		2/8 (25%)		14/184 (7.6%)		11/156 (7.1%)		17/168 (10.1%)		8/60 (13.3%)		21/90 (23.3%)		3/21 (14.3%)		0/18 (0%)		10/50 (20%)		7/51 (13.7%)		6/53 (11.3%)		10/44 (22.7%)		30/125 (24%)		8/62 (12.9%)		1/20 (5%)		31/103 (30.1%)		30/205 (14.6%)		29/132 (22%)		8/153 (5.2%)
Diarrhoea	1/4 (25%)		1/13 (7.7%)		3/15 (20%)		3/21 (14.3%)		1/8 (12.5%)		40/184 (21.7%)		35/156 (22.4%)		0/168 (0%)		9/60 (15%)		12/90 (13.3%)		5/21 (23.8%)		5/18 (27.8%)		14/50 (28%)		14/51 (27.5%)		11/53 (20.8%)		13/44 (29.5%)		31/125 (24.8%)		21/62 (33.9%)		6/20 (30%)		25/103 (24.3%)		40/205 (19.5%)		12/132 (9.1%)		26/153 (17%)
Vomiting	2/4 (50%)		1/13 (7.7%)		2/15 (13.3%)		1/21 (4.8%)		1/8 (12.5%)		32/184 (17.4%)		26/156 (16.7%)		28/168 (16.7%)		15/60 (25%)		19/90 (21.1%)		3/21 (14.3%)		1/18 (5.6%)		16/50 (32%)		5/51 (9.8%)		5/53 (9.4%)		6/44 (13.6%)		27/125 (21.6%)		10/62 (16.1%)		2/20 (10%)		20/103 (19.4%)		37/205 (18%)		21/132 (15.9%)		16/153 (10.5%)
Constipation	0/4 (0%)		0/13 (0%)		2/15 (13.3%)		2/21 (9.5%)		2/8 (25%)		44/184 (23.9%)		44/156 (28.2%)		0/168 (0%)		12/60 (20%)		19/90 (21.1%)		2/21 (9.5%)		0/18 (0%)		5/50 (10%)		10/51 (19.6%)		10/53 (18.9%)		5/44 (11.4%)		26/125 (20.8%)		10/62 (16.1%)		2/20 (10%)		25/103 (24.3%)		48/205 (23.4%)		20/132 (15.2%)		27/153 (17.6%)
Abdominal distension	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		1/21 (4.8%)		0/8 (0%)		6/184 (3.3%)		2/156 (1.3%)		11/168 (6.5%)		3/60 (5%)		4/90 (4.4%)		1/21 (4.8%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		19/125 (15.2%)		6/62 (9.7%)		1/20 (5%)		10/103 (9.7%)		0/205 (0%)		4/132 (3%)		0/153 (0%)
Dry mouth	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		0/21 (0%)		1/8 (12.5%)		5/184 (2.7%)		6/156 (3.8%)		5/168 (3%)		1/60 (1.7%)		4/90 (4.4%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		6/51 (11.8%)		1/53 (1.9%)		3/44 (6.8%)		14/125 (11.2%)		1/62 (1.6%)		1/20 (5%)		6/103 (5.8%)		13/205 (6.3%)		3/132 (2.3%)		6/153 (3.9%)
Gastritis	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		1/21 (4.8%)		0/8 (0%)		5/184 (2.7%)		3/156 (1.9%)		0/168 (0%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dyspepsia	0/4 (0%)		0/13 (0%)		0/15 (0%)		2/21 (9.5%)		0/8 (0%)		5/184 (2.7%)		8/156 (5.1%)		8/168 (4.8%)		4/60 (6.7%)		9/90 (10%)		0/21 (0%)		2/18 (11.1%)		5/50 (10%)		2/51 (3.9%)		1/53 (1.9%)		1/44 (2.3%)		4/125 (3.2%)		2/62 (3.2%)		1/20 (5%)		4/103 (3.9%)		12/205 (5.9%)		8/132 (6.1%)		4/153 (2.6%)
Toothache	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		1/8 (12.5%)		4/184 (2.2%)		3/156 (1.9%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Abdominal discomfort	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		3/168 (1.8%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		4/125 (3.2%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Abdominal pain lower	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		3/156 (1.9%)		2/168 (1.2%)		1/60 (1.7%)		2/90 (2.2%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		2/103 (1.9%)		6/205 (2.9%)		1/132 (0.8%)		1/153 (0.7%)
Aphthous ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Ascites	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		5/168 (3%)		3/60 (5%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		3/51 (5.9%)		3/53 (5.7%)		1/44 (2.3%)		11/125 (8.8%)		0/62 (0%)		0/20 (0%)		12/103 (11.7%)		4/205 (2%)		11/132 (8.3%)		0/153 (0%)
Dental caries	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Dysphagia	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		7/184 (3.8%)		4/156 (2.6%)		4/168 (2.4%)		10/60 (16.7%)		6/90 (6.7%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		2/51 (3.9%)		1/53 (1.9%)		1/44 (2.3%)		2/125 (1.6%)		1/62 (1.6%)		1/20 (5%)		2/103 (1.9%)		6/205 (2.9%)		4/132 (3%)		20/153 (13.1%)
Enteritis	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrooesophageal reflux disease	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		12/184 (6.5%)		4/156 (2.6%)		3/168 (1.8%)		3/60 (5%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		4/50 (8%)		1/51 (2%)		3/53 (5.7%)		2/44 (4.5%)		5/125 (4%)		0/62 (0%)		0/20 (0%)		11/103 (10.7%)		5/205 (2.4%)		3/132 (2.3%)		3/153 (2%)
Oesophagitis	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Stomatitis	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		5/156 (3.2%)		6/168 (3.6%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		1/51 (2%)		3/53 (5.7%)		1/44 (2.3%)		5/125 (4%)		5/62 (8.1%)		1/20 (5%)		4/103 (3.9%)		4/205 (2%)		2/132 (1.5%)		5/153 (3.3%)
Tongue ulceration	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Flatulence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		0/156 (0%)		5/168 (3%)		2/60 (3.3%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		4/125 (3.2%)		0/62 (0%)		1/20 (5%)		3/103 (2.9%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Abdominal pain upper	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		5/156 (3.2%)		0/168 (0%)		6/60 (10%)		12/90 (13.3%)		0/21 (0%)		0/18 (0%)		9/50 (18%)		1/51 (2%)		4/53 (7.5%)		2/44 (4.5%)		7/125 (5.6%)		3/62 (4.8%)		0/20 (0%)		5/103 (4.9%)		7/205 (3.4%)		14/132 (10.6%)		2/153 (1.3%)
Odynophagia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		3/153 (2%)
Rectal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Coeliac disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Colitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Duodenitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Epigastric discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Faecaloma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Faeces discoloured	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Gastric haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Gingival pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		2/153 (1.3%)
Gingival ulceration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haematemesis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hiatus hernia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Lip oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lip swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lower gastrointestinal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Melaena	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Oesophageal ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oral pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		2/132 (1.5%)		2/153 (1.3%)
Paraesthesia oral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Proctalgia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Retroperitoneal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tongue geographic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tongue haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tooth disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haemorrhoids	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		4/156 (2.6%)		1/168 (0.6%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Anal incontinence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Diverticulum	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Frequent bowel movements	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gingival swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haematochezia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Oesophageal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Oral dysaesthesia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Perianal erythema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Poor dental condition	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Salivary hypersecretion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		2/153 (1.3%)
Abdominal tenderness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		3/168 (1.8%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cheilitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Abdominal rigidity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Breath odour	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Faeces hard	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Glossitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hypoaesthesia oral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Mouth ulceration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		2/153 (1.3%)
Retching	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Swollen tongue	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tongue blistering	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eructation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Gastric ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gingival bleeding	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Impaired gastric emptying	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		4/132 (3%)		0/153 (0%)
Intestinal obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Obstruction gastric	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oesophageal obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oesophageal stenosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pancreatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peptic ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rectal tenesmus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Salivary gland mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Anal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Aptyalism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Noninfective sialoadenitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lip blister	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Subileus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Anorectal discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Glossodynia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Portal hypertensive gastropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Varices oesophageal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal sounds abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Large intestine polyp	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lip pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Food poisoning	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ileus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Lip dry	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Enterocutaneous fistula	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Faeces soft	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Functional gastrointestinal disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Large intestinal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Noninfective gingivitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rectal discharge	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Anal pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Gastrointestinal disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Inguinal hernia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		1/20 (5%)		0/103 (0%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Abdominal mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bowel movement irregularity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Diarrhoea haemorrhagic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tongue discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Abdominal hernia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Umbilical hernia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Mucous stools	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Autoimmune colitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Chronic gastritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Defaecation urgency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Diverticulum intestinal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Enterocolitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Gingival disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Lip ulceration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Mouth cyst	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Oral disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Oral mucosal blistering	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pancreatic duct dilatation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pancreatitis acute	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Gastrointestinal fistula	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Oesophageal fistula	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Mouth haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		3/153 (2%)
Tongue oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Mouth swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Regurgitation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Salivary gland pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tongue necrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Haemorrhoidal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
General disorders
Fatigue	2/4 (50%)		7/13 (53.8%)		13/15 (86.7%)		6/21 (28.6%)		3/8 (37.5%)		74/184 (40.2%)		71/156 (45.5%)		66/168 (39.3%)		13/60 (21.7%)		20/90 (22.2%)		5/21 (23.8%)		7/18 (38.9%)		17/50 (34%)		13/51 (25.5%)		17/53 (32.1%)		17/44 (38.6%)		36/125 (28.8%)		27/62 (43.5%)		10/20 (50%)		38/103 (36.9%)		72/205 (35.1%)		37/132 (28%)		41/153 (26.8%)
Pyrexia	4/4 (100%)		2/13 (15.4%)		4/15 (26.7%)		4/21 (19%)		0/8 (0%)		19/184 (10.3%)		20/156 (12.8%)		20/168 (11.9%)		7/60 (11.7%)		6/90 (6.7%)		4/21 (19%)		2/18 (11.1%)		15/50 (30%)		5/51 (9.8%)		8/53 (15.1%)		6/44 (13.6%)		10/125 (8%)		10/62 (16.1%)		2/20 (10%)		16/103 (15.5%)		33/205 (16.1%)		21/132 (15.9%)		31/153 (20.3%)
Influenza like illness	1/4 (25%)		1/13 (7.7%)		4/15 (26.7%)		7/21 (33.3%)		0/8 (0%)		9/184 (4.9%)		5/156 (3.2%)		14/168 (8.3%)		0/60 (0%)		5/90 (5.6%)		2/21 (9.5%)		3/18 (16.7%)		3/50 (6%)		2/51 (3.9%)		1/53 (1.9%)		2/44 (4.5%)		8/125 (6.4%)		4/62 (6.5%)		1/20 (5%)		5/103 (4.9%)		6/205 (2.9%)		3/132 (2.3%)		6/153 (3.9%)
Chills	1/4 (25%)		0/13 (0%)		2/15 (13.3%)		2/21 (9.5%)		1/8 (12.5%)		22/184 (12%)		15/156 (9.6%)		8/168 (4.8%)		3/60 (5%)		6/90 (6.7%)		1/21 (4.8%)		2/18 (11.1%)		7/50 (14%)		9/51 (17.6%)		11/53 (20.8%)		6/44 (13.6%)		11/125 (8.8%)		9/62 (14.5%)		0/20 (0%)		16/103 (15.5%)		18/205 (8.8%)		15/132 (11.4%)		14/153 (9.2%)
Oedema peripheral	1/4 (25%)		2/13 (15.4%)		0/15 (0%)		1/21 (4.8%)		1/8 (12.5%)		26/184 (14.1%)		27/156 (17.3%)		17/168 (10.1%)		1/60 (1.7%)		2/90 (2.2%)		2/21 (9.5%)		1/18 (5.6%)		11/50 (22%)		7/51 (13.7%)		7/53 (13.2%)		7/44 (15.9%)		25/125 (20%)		6/62 (9.7%)		2/20 (10%)		21/103 (20.4%)		31/205 (15.1%)		21/132 (15.9%)		7/153 (4.6%)
Malaise	1/4 (25%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		6/184 (3.3%)		7/156 (4.5%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		2/51 (3.9%)		1/53 (1.9%)		2/44 (4.5%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		2/132 (1.5%)		1/153 (0.7%)
Peripheral swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		2/8 (25%)		3/184 (1.6%)		3/156 (1.9%)		6/168 (3.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		3/44 (6.8%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		4/103 (3.9%)		4/205 (2%)		0/132 (0%)		0/153 (0%)
Asthenia	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		11/184 (6%)		13/156 (8.3%)		15/168 (8.9%)		5/60 (8.3%)		8/90 (8.9%)		0/21 (0%)		0/18 (0%)		7/50 (14%)		7/51 (13.7%)		9/53 (17%)		8/44 (18.2%)		0/125 (0%)		12/62 (19.4%)		2/20 (10%)		6/103 (5.8%)		25/205 (12.2%)		11/132 (8.3%)		19/153 (12.4%)
Chest pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		1/184 (0.5%)		3/156 (1.9%)		7/168 (4.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		2/53 (3.8%)		1/44 (2.3%)		1/125 (0.8%)		1/62 (1.6%)		2/20 (10%)		0/103 (0%)		4/205 (2%)		1/132 (0.8%)		0/153 (0%)
Facial pain	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		4/153 (2.6%)
Injection site reaction	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mucosal inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Non-cardiac chest pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		15/184 (8.2%)		12/156 (7.7%)		9/168 (5.4%)		2/60 (3.3%)		5/90 (5.6%)		1/21 (4.8%)		0/18 (0%)		5/50 (10%)		1/51 (2%)		5/53 (9.4%)		2/44 (4.5%)		5/125 (4%)		4/62 (6.5%)		2/20 (10%)		9/103 (8.7%)		4/205 (2%)		6/132 (4.5%)		5/153 (3.3%)
Pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		7/184 (3.8%)		7/156 (4.5%)		7/168 (4.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		3/53 (5.7%)		3/44 (6.8%)		5/125 (4%)		1/62 (1.6%)		1/20 (5%)		1/103 (1%)		2/205 (1%)		3/132 (2.3%)		4/153 (2.6%)
Gait disturbance	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		2/156 (1.3%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		4/132 (3%)		2/153 (1.3%)
Axillary pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		0/156 (0%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		4/168 (2.4%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Feeling cold	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Localised oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		3/125 (2.4%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Chest discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		5/156 (3.2%)		4/168 (2.4%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Early satiety	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Face oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		2/132 (1.5%)		8/153 (5.2%)
Feeling hot	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Nodule	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Temperature intolerance	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Adverse drug reaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cyst	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Feeling jittery	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Infusion site extravasation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		2/153 (1.3%)
Polyp	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Secretion discharge	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Disease progression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		3/132 (2.3%)		0/153 (0%)
Administration site extravasation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site erythema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
General physical health deterioration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		1/132 (0.8%)		3/153 (2%)
Injection site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Medical device site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Medical device site rash	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oedema due to cardiac disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Performance status decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Xerosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Crying	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Generalised oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Catheter site swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site warmth	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Local swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Medical device pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thirst	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Administration site erythema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site extravasation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infusion site swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Drug intolerance	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Granuloma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Implant site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site dermatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site rash	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Catheter site inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Complication associated with device	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Gait deviation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hernia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Injection site pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Suprapubic pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Systemic inflammatory response syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hypothermia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Medical device site erythema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Hyperthermia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Injection site oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatobiliary disorders
Biliary dilatation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cholelithiasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Cholecystitis acute	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cholecystitis chronic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Autoimmune hepatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		3/168 (1.8%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hepatomegaly	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bile duct obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatic pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hyperbilirubinaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Liver disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatocellular injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		4/153 (2.6%)
Cholangitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cholestasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		2/132 (1.5%)		0/153 (0%)
Cholecystitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Drug-induced liver injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hepatic steatosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hepatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Ischaemic hepatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Immune system disorders
Hypersensitivity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Seasonal allergy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		3/156 (1.9%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Contrast media reaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Drug hypersensitivity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		3/156 (1.9%)		1/168 (0.6%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Autoimmune disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Type IV hypersensitivity reaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Contrast media allergy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		3/62 (4.8%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Anaphylactic reaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infections and infestations
Upper respiratory tract infection	1/4 (25%)		2/13 (15.4%)		2/15 (13.3%)		2/21 (9.5%)		2/8 (25%)		21/184 (11.4%)		21/156 (13.5%)		5/168 (3%)		0/60 (0%)		8/90 (8.9%)		0/21 (0%)		1/18 (5.6%)		4/50 (8%)		5/51 (9.8%)		6/53 (11.3%)		2/44 (4.5%)		11/125 (8.8%)		7/62 (11.3%)		1/20 (5%)		7/103 (6.8%)		12/205 (5.9%)		2/132 (1.5%)		10/153 (6.5%)
Pneumonia	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		0/21 (0%)		1/8 (12.5%)		15/184 (8.2%)		9/156 (5.8%)		3/168 (1.8%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		5/125 (4%)		4/62 (6.5%)		1/20 (5%)		2/103 (1.9%)		5/205 (2.4%)		2/132 (1.5%)		7/153 (4.6%)
Urinary tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		2/21 (9.5%)		1/8 (12.5%)		19/184 (10.3%)		14/156 (9%)		17/168 (10.1%)		2/60 (3.3%)		2/90 (2.2%)		0/21 (0%)		1/18 (5.6%)		4/50 (8%)		7/51 (13.7%)		3/53 (5.7%)		7/44 (15.9%)		21/125 (16.8%)		8/62 (12.9%)		2/20 (10%)		18/103 (17.5%)		47/205 (22.9%)		6/132 (4.5%)		8/153 (5.2%)
Conjunctivitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		2/21 (9.5%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		6/62 (9.7%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Hordeolum	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		1/8 (12.5%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bronchitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		13/184 (7.1%)		15/156 (9.6%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		1/44 (2.3%)		3/125 (2.4%)		2/62 (3.2%)		2/20 (10%)		1/103 (1%)		6/205 (2.9%)		1/132 (0.8%)		6/153 (3.9%)
Enterocolitis viral	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Localised infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Otitis media	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sinusitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		6/184 (3.3%)		3/156 (1.9%)		2/168 (1.2%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		1/44 (2.3%)		4/125 (3.2%)		1/62 (1.6%)		0/20 (0%)		2/103 (1.9%)		4/205 (2%)		1/132 (0.8%)		5/153 (3.3%)
Sinusitis bacterial	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		4/168 (2.4%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Staphylococcal infection	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Viral upper respiratory tract infection	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		8/90 (8.9%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Oral candidiasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		6/156 (3.8%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		2/51 (3.9%)		1/53 (1.9%)		1/44 (2.3%)		3/125 (2.4%)		2/62 (3.2%)		0/20 (0%)		2/103 (1.9%)		6/205 (2.9%)		3/132 (2.3%)		4/153 (2.6%)
Herpes zoster	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		4/156 (2.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		2/51 (3.9%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		2/205 (1%)		2/132 (1.5%)		1/153 (0.7%)
Nasopharyngitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		6/156 (3.8%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		9/50 (18%)		4/51 (7.8%)		1/53 (1.9%)		2/44 (4.5%)		2/125 (1.6%)		8/62 (12.9%)		2/20 (10%)		1/103 (1%)		6/205 (2.9%)		0/132 (0%)		4/153 (2.6%)
Tooth infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		3/153 (2%)
Abscess limb	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Candida infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Gastroenteritis viral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lower respiratory tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Lung infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		6/156 (3.8%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		2/153 (1.3%)
Asymptomatic bacteriuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bacterial disease carrier	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bacteriuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chest wall abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Clostridium difficile infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Cystitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		4/205 (2%)		1/132 (0.8%)		0/153 (0%)
Ear infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Eye infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Fungal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Furuncle	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Helicobacter infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		2/132 (1.5%)		0/153 (0%)
Influenza	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		2/168 (1.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		3/62 (4.8%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Lung abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mucosal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nail infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oral fungal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Oral infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Pharyngitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pharyngitis streptococcal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rash pustular	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		2/44 (4.5%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Respiratory tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Skin candida	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Stenotrophomonas infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tooth abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		2/153 (1.3%)
Vaginal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vulval abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Vulvovaginal mycotic infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		3/125 (2.4%)		0/62 (0%)		2/20 (10%)		2/103 (1.9%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Cellulitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		4/156 (2.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		2/44 (4.5%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		2/103 (1.9%)		4/205 (2%)		0/132 (0%)		0/153 (0%)
Skin infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		3/156 (1.9%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		2/153 (1.3%)
Erysipelas	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Fungal skin infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Arteritis infective	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Atypical pneumonia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bacteraemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cystitis klebsiella	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Fungal oesophagitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastroenteritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		1/20 (5%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Herpes simplex	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infected dermal cyst	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Labyrinthitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Laryngitis viral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mycobacterial infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oral herpes	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		1/153 (0.7%)
Rhinitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		4/62 (6.5%)		1/20 (5%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		5/153 (3.3%)
Sputum purulent	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Viral infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Onychomycosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Angular cheilitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Bacterial rhinitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Device related infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Impetigo	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tongue fungal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tracheitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Acarodermatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Diverticulitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Endophthalmitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Fungal pharyngitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gingivitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Laryngitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Lice infestation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Periodontitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tonsillitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vestibulitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Viral rhinitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Abscess neck	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bacterial sepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Haemophilus infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Herpes virus infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Myringitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oesophageal candidiasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Folliculitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Body tinea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Osteomyelitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulpitis dental	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tinea versicolour	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Trichomoniasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Wound infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Conjunctivitis viral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tinea infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Abdominal abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Acute sinusitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Lip infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Penile infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Perirectal abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Abdominal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Genital infection female	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Anal abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bronchitis viral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Catheter site infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mastitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Molluscum contagiosum	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Diarrhoea infectious	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal viral infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Clostridium difficile colitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Coccidioidomycosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pyelonephritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pyuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Stoma site infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Urinary tract infection bacterial	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Herpes dermatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Infected skin ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Kidney infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Paronychia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pelvic abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pneumonia cytomegaloviral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Septic shock	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Tinea pedis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urinary tract infection enterococcal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urinary tract infection fungal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Empyema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Endocarditis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Escherichia urinary tract infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Meningitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Stoma site cellulitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Vascular device infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Beta haemolytic streptococcal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Clostridium colitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Enterocolitis infectious	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Gingival abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Medical device site infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Ophthalmic herpes zoster	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Purulent discharge	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Upper respiratory fungal infection	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Abscess	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Device related sepsis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Injury, poisoning and procedural complications
Infusion related reaction	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		3/21 (14.3%)		4/8 (50%)		35/184 (19%)		25/156 (16%)		24/168 (14.3%)		6/60 (10%)		13/90 (14.4%)		6/21 (28.6%)		4/18 (22.2%)		6/50 (12%)		12/51 (23.5%)		19/53 (35.8%)		9/44 (20.5%)		17/125 (13.6%)		12/62 (19.4%)		5/20 (25%)		17/103 (16.5%)		47/205 (22.9%)		18/132 (13.6%)		13/153 (8.5%)
Fall	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		8/184 (4.3%)		12/156 (7.7%)		6/168 (3.6%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		1/51 (2%)		3/53 (5.7%)		4/44 (9.1%)		3/125 (2.4%)		1/62 (1.6%)		2/20 (10%)		7/103 (6.8%)		9/205 (4.4%)		5/132 (3.8%)		8/153 (5.2%)
Procedural pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		1/184 (0.5%)		4/156 (2.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Contusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		5/156 (3.2%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		2/53 (3.8%)		0/44 (0%)		5/125 (4%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		1/205 (0.5%)		3/132 (2.3%)		0/153 (0%)
Spinal compression fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Animal bite	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Foot fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Incision site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Muscle strain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin laceration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		4/156 (2.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Vascular access complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ear injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypobarism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Limb injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Procedural anxiety	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Procedural haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiation necrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiation pneumonitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radius fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Rib fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		4/156 (2.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Upper limb fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eschar	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin abrasion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Anaemia postoperative	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Brain contusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Burn oesophageal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cartilage injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Incision site haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Jaw fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Ligament sprain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Post-thoracotomy pain syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Post-traumatic pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin wound	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skull fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Spinal fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Thoracic vertebral fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
VIIth nerve injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Wound	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Incision site complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Joint injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Laceration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Traumatic haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Wound secretion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Excoriation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Arthropod bite	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Lumbar vertebral fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiation injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urostomy complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cervical vertebral fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Face injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chest injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Joint dislocation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiation retinopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiation skin injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Stoma site pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Perineal injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Humerus fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Testicular injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pneumothorax traumatic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Stoma site haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thermal burn	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Sunburn	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tendon rupture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Post procedural inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lip injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Facial bones fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Clavicle fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Concussion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Subdural haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrostomy tube site complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Hand fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Meniscus injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Tooth fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Accidental overdose	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Confusion postoperative	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Foreign body in eye	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Fractured sacrum	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Incision site pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Lower limb fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Seroma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Stoma site pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Suture related complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Bite	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Radiation associated pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Epicondylitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Eye injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Head injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Post procedural complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Procedural hypotension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Procedural nausea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Radiation fibrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Skin injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Stoma complication	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Investigations
Aspartate aminotransferase increased	2/4 (50%)		2/13 (15.4%)		1/15 (6.7%)		5/21 (23.8%)		1/8 (12.5%)		4/184 (2.2%)		4/156 (2.6%)		14/168 (8.3%)		3/60 (5%)		10/90 (11.1%)		5/21 (23.8%)		2/18 (11.1%)		7/50 (14%)		3/51 (5.9%)		3/53 (5.7%)		4/44 (9.1%)		5/125 (4%)		3/62 (4.8%)		0/20 (0%)		3/103 (2.9%)		15/205 (7.3%)		19/132 (14.4%)		5/153 (3.3%)
Weight decreased	1/4 (25%)		1/13 (7.7%)		5/15 (33.3%)		1/21 (4.8%)		0/8 (0%)		27/184 (14.7%)		45/156 (28.8%)		13/168 (7.7%)		21/60 (35%)		19/90 (21.1%)		3/21 (14.3%)		1/18 (5.6%)		9/50 (18%)		8/51 (15.7%)		10/53 (18.9%)		15/44 (34.1%)		22/125 (17.6%)		3/62 (4.8%)		3/20 (15%)		18/103 (17.5%)		36/205 (17.6%)		22/132 (16.7%)		34/153 (22.2%)
Weight increased	0/4 (0%)		3/13 (23.1%)		0/15 (0%)		3/21 (14.3%)		1/8 (12.5%)		13/184 (7.1%)		9/156 (5.8%)		2/168 (1.2%)		2/60 (3.3%)		4/90 (4.4%)		1/21 (4.8%)		1/18 (5.6%)		8/50 (16%)		0/51 (0%)		2/53 (3.8%)		7/44 (15.9%)		11/125 (8.8%)		2/62 (3.2%)		2/20 (10%)		8/103 (7.8%)		8/205 (3.9%)		3/132 (2.3%)		2/153 (1.3%)
White blood cell count decreased	1/4 (25%)		2/13 (15.4%)		3/15 (20%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		2/21 (9.5%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		2/153 (1.3%)
Alanine aminotransferase increased	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		3/21 (14.3%)		1/8 (12.5%)		3/184 (1.6%)		7/156 (4.5%)		11/168 (6.5%)		2/60 (3.3%)		7/90 (7.8%)		4/21 (19%)		2/18 (11.1%)		9/50 (18%)		2/51 (3.9%)		2/53 (3.8%)		2/44 (4.5%)		4/125 (3.2%)		2/62 (3.2%)		0/20 (0%)		3/103 (2.9%)		8/205 (3.9%)		10/132 (7.6%)		5/153 (3.3%)
Blood alkaline phosphatase increased	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		2/21 (9.5%)		1/8 (12.5%)		2/184 (1.1%)		3/156 (1.9%)		7/168 (4.2%)		4/60 (6.7%)		3/90 (3.3%)		7/21 (33.3%)		1/18 (5.6%)		5/50 (10%)		2/51 (3.9%)		2/53 (3.8%)		2/44 (4.5%)		3/125 (2.4%)		1/62 (1.6%)		2/20 (10%)		3/103 (2.9%)		14/205 (6.8%)		11/132 (8.3%)		3/153 (2%)
Blood creatine phosphokinase increased	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		3/21 (14.3%)		0/8 (0%)		4/184 (2.2%)		4/156 (2.6%)		1/168 (0.6%)		1/60 (1.7%)		4/90 (4.4%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		3/125 (2.4%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Blood creatinine increased	2/4 (50%)		0/13 (0%)		0/15 (0%)		2/21 (9.5%)		0/8 (0%)		7/184 (3.8%)		11/156 (7.1%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		1/21 (4.8%)		2/18 (11.1%)		7/50 (14%)		0/51 (0%)		4/53 (7.5%)		4/44 (9.1%)		3/125 (2.4%)		7/62 (11.3%)		2/20 (10%)		10/103 (9.7%)		22/205 (10.7%)		6/132 (4.5%)		2/153 (1.3%)
Lipase increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		4/21 (19%)		0/8 (0%)		5/184 (2.7%)		8/156 (5.1%)		0/168 (0%)		2/60 (3.3%)		2/90 (2.2%)		3/21 (14.3%)		1/18 (5.6%)		4/50 (8%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		4/125 (3.2%)		8/62 (12.9%)		3/20 (15%)		2/103 (1.9%)		6/205 (2.9%)		2/132 (1.5%)		2/153 (1.3%)
Lymphocyte count decreased	0/4 (0%)		2/13 (15.4%)		2/15 (13.3%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		6/168 (3.6%)		0/60 (0%)		0/90 (0%)		7/21 (33.3%)		0/18 (0%)		5/50 (10%)		0/51 (0%)		7/53 (13.2%)		3/44 (6.8%)		3/125 (2.4%)		1/62 (1.6%)		1/20 (5%)		5/103 (4.9%)		3/205 (1.5%)		4/132 (3%)		7/153 (4.6%)
Amylase increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		2/21 (9.5%)		1/8 (12.5%)		5/184 (2.7%)		6/156 (3.8%)		0/168 (0%)		1/60 (1.7%)		2/90 (2.2%)		1/21 (4.8%)		2/18 (11.1%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		3/125 (2.4%)		1/62 (1.6%)		2/20 (10%)		3/103 (2.9%)		6/205 (2.9%)		1/132 (0.8%)		0/153 (0%)
Gamma-glutamyltransferase increased	1/4 (25%)		0/13 (0%)		1/15 (6.7%)		1/21 (4.8%)		0/8 (0%)		4/184 (2.2%)		5/156 (3.2%)		6/168 (3.6%)		1/60 (1.7%)		4/90 (4.4%)		3/21 (14.3%)		1/18 (5.6%)		4/50 (8%)		2/51 (3.9%)		1/53 (1.9%)		5/44 (11.4%)		4/125 (3.2%)		3/62 (4.8%)		0/20 (0%)		0/103 (0%)		6/205 (2.9%)		5/132 (3.8%)		2/153 (1.3%)
Platelet count decreased	0/4 (0%)		0/13 (0%)		3/15 (20%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		2/168 (1.2%)		2/60 (3.3%)		2/90 (2.2%)		3/21 (14.3%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		4/205 (2%)		4/132 (3%)		1/153 (0.7%)
Neutrophil count decreased	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Activated partial thromboplastin time prolonged	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		4/156 (2.6%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		2/21 (9.5%)		0/18 (0%)		1/50 (2%)		2/51 (3.9%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		2/205 (1%)		3/132 (2.3%)		1/153 (0.7%)
Blood bilirubin increased	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		3/168 (1.8%)		3/60 (5%)		4/90 (4.4%)		1/21 (4.8%)		1/18 (5.6%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		2/125 (1.6%)		1/62 (1.6%)		0/20 (0%)		2/103 (1.9%)		3/205 (1.5%)		3/132 (2.3%)		1/153 (0.7%)
Blood glucose increased	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Blood pressure increased	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
CD4 lymphocytes decreased	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Electrocardiogram QT prolonged	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		5/50 (10%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		4/205 (2%)		1/132 (0.8%)		4/153 (2.6%)
Prothrombin time prolonged	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
C-reactive protein increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		2/125 (1.6%)		1/62 (1.6%)		1/20 (5%)		2/103 (1.9%)		1/205 (0.5%)		3/132 (2.3%)		3/153 (2%)
Blood thyroid stimulating hormone increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		2/62 (3.2%)		2/20 (10%)		2/103 (1.9%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Breath sounds abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		2/44 (4.5%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haemoglobin decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Heart rate increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
International normalised ratio increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		2/168 (1.2%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		2/62 (3.2%)		1/20 (5%)		2/103 (1.9%)		4/205 (2%)		0/132 (0%)		0/153 (0%)
Rheumatoid factor increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Troponin I increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
White blood cell count increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Antinuclear antibody positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Bacterial test positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood follicle stimulating hormone increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood lactate dehydrogenase increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		2/20 (10%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Blood magnesium decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Blood phosphorus decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Blood uric acid increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cortisol increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Electrophoresis protein abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Fibrin D dimer increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haematocrit decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Heart rate irregular	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Lymphocyte count	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lymphocyte count increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mean cell volume decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary physical examination abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Reticulocyte percentage increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Transaminases increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Troponin increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Urinary sediment present	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urine leukocyte esterase positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Human epidermal growth factor receptor decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Intestinal transit time abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Neutrophil count increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nitrite urine present	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
White blood cells urine positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood creatine phosphokinase decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood potassium decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Ejection fraction decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Electrocardiogram T wave abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatic enzyme increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Liver function test increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Monocyte count increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Antineutrophil cytoplasmic antibody increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood iron decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vitamin D decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urine ketone body present	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood albumin decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Body temperature increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		3/153 (2%)
Corneal reflex decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ammonia increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Glycosylated haemoglobin increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urobilinogen urine increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Vitamin B12 decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Platelet count increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Antinuclear antibody increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Respiratory rate increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin turgor decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood cholesterol increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Streptobacillus test positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood sodium decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Carbohydrate antigen 125 increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Electrocardiogram ST segment abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lymph node palpable	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Red blood cells urine positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Waist circumference increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Blood urea increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Glomerular filtration rate increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Reticulocyte count increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thyroxine decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Blood creatine increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Glomerular filtration rate decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Occult blood positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Protein total decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		2/132 (1.5%)		0/153 (0%)
Prothrombin level increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sputum abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Thyroid hormones increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urine output decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Blood potassium increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Cardiac murmur	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Blood magnesium increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Blood testosterone decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Klebsiella test positive	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Transferrin increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Transferrin saturation decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Amylase decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Blood calcium decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Blood chloride decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Blood lactic acid increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Computerised tomogram thorax abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Eastern Cooperative Oncology Group performance status worsened	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Electrocardiogram QRS complex prolonged	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Electrocardiogram T wave peaked	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Electrocardiogram abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Rheumatoid factor quantitative increased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Metabolism and nutrition disorders
Hyperglycaemia	1/4 (25%)		2/13 (15.4%)		3/15 (20%)		0/21 (0%)		1/8 (12.5%)		11/184 (6%)		6/156 (3.8%)		4/168 (2.4%)		1/60 (1.7%)		4/90 (4.4%)		4/21 (19%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		5/53 (9.4%)		4/44 (9.1%)		2/125 (1.6%)		4/62 (6.5%)		0/20 (0%)		4/103 (3.9%)		8/205 (3.9%)		4/132 (3%)		2/153 (1.3%)
Hypoalbuminaemia	2/4 (50%)		2/13 (15.4%)		1/15 (6.7%)		1/21 (4.8%)		0/8 (0%)		8/184 (4.3%)		6/156 (3.8%)		6/168 (3.6%)		3/60 (5%)		3/90 (3.3%)		3/21 (14.3%)		0/18 (0%)		4/50 (8%)		0/51 (0%)		9/53 (17%)		2/44 (4.5%)		5/125 (4%)		2/62 (3.2%)		2/20 (10%)		5/103 (4.9%)		7/205 (3.4%)		9/132 (6.8%)		8/153 (5.2%)
Hypokalaemia	1/4 (25%)		4/13 (30.8%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		17/184 (9.2%)		17/156 (10.9%)		9/168 (5.4%)		6/60 (10%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		6/50 (12%)		6/51 (11.8%)		2/53 (3.8%)		4/44 (9.1%)		8/125 (6.4%)		1/62 (1.6%)		1/20 (5%)		11/103 (10.7%)		10/205 (4.9%)		15/132 (11.4%)		11/153 (7.2%)
Hyponatraemia	2/4 (50%)		2/13 (15.4%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		16/184 (8.7%)		17/156 (10.9%)		3/168 (1.8%)		6/60 (10%)		4/90 (4.4%)		1/21 (4.8%)		0/18 (0%)		6/50 (12%)		2/51 (3.9%)		2/53 (3.8%)		6/44 (13.6%)		7/125 (5.6%)		4/62 (6.5%)		3/20 (15%)		12/103 (11.7%)		18/205 (8.8%)		12/132 (9.1%)		11/153 (7.2%)
Decreased appetite	1/4 (25%)		0/13 (0%)		2/15 (13.3%)		0/21 (0%)		0/8 (0%)		42/184 (22.8%)		36/156 (23.1%)		33/168 (19.6%)		17/60 (28.3%)		14/90 (15.6%)		1/21 (4.8%)		0/18 (0%)		13/50 (26%)		9/51 (17.6%)		12/53 (22.6%)		9/44 (20.5%)		21/125 (16.8%)		17/62 (27.4%)		3/20 (15%)		19/103 (18.4%)		53/205 (25.9%)		31/132 (23.5%)		18/153 (11.8%)
Hypomagnesaemia	0/4 (0%)		2/13 (15.4%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		13/184 (7.1%)		5/156 (3.2%)		3/168 (1.8%)		3/60 (5%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		7/50 (14%)		1/51 (2%)		3/53 (5.7%)		2/44 (4.5%)		9/125 (7.2%)		0/62 (0%)		1/20 (5%)		13/103 (12.6%)		12/205 (5.9%)		9/132 (6.8%)		7/153 (4.6%)
Hyperkalaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		1/8 (12.5%)		5/184 (2.7%)		4/156 (2.6%)		1/168 (0.6%)		2/60 (3.3%)		1/90 (1.1%)		1/21 (4.8%)		1/18 (5.6%)		4/50 (8%)		0/51 (0%)		1/53 (1.9%)		2/44 (4.5%)		1/125 (0.8%)		4/62 (6.5%)		3/20 (15%)		0/103 (0%)		10/205 (4.9%)		4/132 (3%)		5/153 (3.3%)
Hypocalcaemia	2/4 (50%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		1/168 (0.6%)		3/60 (5%)		3/90 (3.3%)		1/21 (4.8%)		0/18 (0%)		5/50 (10%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		3/103 (2.9%)		3/205 (1.5%)		6/132 (4.5%)		5/153 (3.3%)
Hypertriglyceridaemia	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		4/156 (2.6%)		1/168 (0.6%)		0/60 (0%)		2/90 (2.2%)		1/21 (4.8%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		2/53 (3.8%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Hypochloraemia	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypophosphataemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		11/184 (6%)		6/156 (3.8%)		2/168 (1.2%)		3/60 (5%)		2/90 (2.2%)		2/21 (9.5%)		0/18 (0%)		8/50 (16%)		4/51 (7.8%)		1/53 (1.9%)		2/44 (4.5%)		2/125 (1.6%)		1/62 (1.6%)		2/20 (10%)		4/103 (3.9%)		12/205 (5.9%)		3/132 (2.3%)		9/153 (5.9%)
Dehydration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		18/184 (9.8%)		17/156 (10.9%)		6/168 (3.6%)		1/60 (1.7%)		6/90 (6.7%)		0/21 (0%)		0/18 (0%)		4/50 (8%)		6/51 (11.8%)		6/53 (11.3%)		4/44 (9.1%)		9/125 (7.2%)		5/62 (8.1%)		1/20 (5%)		10/103 (9.7%)		18/205 (8.8%)		14/132 (10.6%)		7/153 (4.6%)
Hypercalcaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		8/184 (4.3%)		3/156 (1.9%)		2/168 (1.2%)		1/60 (1.7%)		0/90 (0%)		2/21 (9.5%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		4/44 (9.1%)		1/125 (0.8%)		5/62 (8.1%)		3/20 (15%)		0/103 (0%)		6/205 (2.9%)		3/132 (2.3%)		11/153 (7.2%)
Hypovolaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Cachexia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Malnutrition	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		3/103 (2.9%)		1/205 (0.5%)		2/132 (1.5%)		2/153 (1.3%)
Fluid overload	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Fluid retention	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hyperphosphataemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Hyperuricaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		2/60 (3.3%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		1/44 (2.3%)		2/125 (1.6%)		1/62 (1.6%)		0/20 (0%)		2/103 (1.9%)		4/205 (2%)		0/132 (0%)		1/153 (0.7%)
Iron deficiency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Steroid diabetes	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vitamin B12 deficiency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypercholesterolaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		1/53 (1.9%)		2/44 (4.5%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Abnormal loss of weight	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Appetite disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperamylasaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperlipidaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypoglycaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		3/153 (2%)
Hypophagia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Diabetes mellitus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hypermagnesaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Vitamin D deficiency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypernatraemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		2/103 (1.9%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Acidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hyperphagia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Type 2 diabetes mellitus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		3/103 (2.9%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Gout	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Iron overload	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Increased appetite	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Polydipsia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypoproteinaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Uraemic acidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lactic acidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Folate deficiency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Metabolic acidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		2/132 (1.5%)		0/153 (0%)
Vitamin B1 deficiency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/4 (0%)		0/13 (0%)		3/15 (20%)		1/21 (4.8%)		3/8 (37.5%)		30/184 (16.3%)		29/156 (18.6%)		24/168 (14.3%)		7/60 (11.7%)		10/90 (11.1%)		2/21 (9.5%)		3/18 (16.7%)		10/50 (20%)		7/51 (13.7%)		11/53 (20.8%)		4/44 (9.1%)		15/125 (12%)		13/62 (21%)		2/20 (10%)		13/103 (12.6%)		33/205 (16.1%)		15/132 (11.4%)		14/153 (9.2%)
Myalgia	1/4 (25%)		1/13 (7.7%)		0/15 (0%)		3/21 (14.3%)		1/8 (12.5%)		14/184 (7.6%)		10/156 (6.4%)		6/168 (3.6%)		2/60 (3.3%)		6/90 (6.7%)		1/21 (4.8%)		0/18 (0%)		4/50 (8%)		4/51 (7.8%)		6/53 (11.3%)		1/44 (2.3%)		9/125 (7.2%)		9/62 (14.5%)		3/20 (15%)		8/103 (7.8%)		9/205 (4.4%)		8/132 (6.1%)		10/153 (6.5%)
Pain in extremity	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		2/21 (9.5%)		2/8 (25%)		11/184 (6%)		24/156 (15.4%)		14/168 (8.3%)		1/60 (1.7%)		5/90 (5.6%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		4/51 (7.8%)		5/53 (9.4%)		3/44 (6.8%)		4/125 (3.2%)		7/62 (11.3%)		1/20 (5%)		8/103 (7.8%)		13/205 (6.3%)		6/132 (4.5%)		7/153 (4.6%)
Arthralgia	0/4 (0%)		0/13 (0%)		2/15 (13.3%)		1/21 (4.8%)		1/8 (12.5%)		24/184 (13%)		20/156 (12.8%)		26/168 (15.5%)		2/60 (3.3%)		8/90 (8.9%)		1/21 (4.8%)		5/18 (27.8%)		5/50 (10%)		8/51 (15.7%)		7/53 (13.2%)		6/44 (13.6%)		15/125 (12%)		12/62 (19.4%)		6/20 (30%)		12/103 (11.7%)		21/205 (10.2%)		10/132 (7.6%)		10/153 (6.5%)
Flank pain	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		2/21 (9.5%)		1/8 (12.5%)		6/184 (3.3%)		4/156 (2.6%)		4/168 (2.4%)		0/60 (0%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		2/51 (3.9%)		2/53 (3.8%)		1/44 (2.3%)		2/125 (1.6%)		1/62 (1.6%)		1/20 (5%)		4/103 (3.9%)		9/205 (4.4%)		3/132 (2.3%)		0/153 (0%)
Muscle spasms	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		10/184 (5.4%)		3/156 (1.9%)		10/168 (6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		3/51 (5.9%)		3/53 (5.7%)		2/44 (4.5%)		9/125 (7.2%)		5/62 (8.1%)		1/20 (5%)		7/103 (6.8%)		8/205 (3.9%)		0/132 (0%)		2/153 (1.3%)
Muscular weakness	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		1/21 (4.8%)		0/8 (0%)		7/184 (3.8%)		8/156 (5.1%)		4/168 (2.4%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		4/50 (8%)		2/51 (3.9%)		0/53 (0%)		1/44 (2.3%)		4/125 (3.2%)		4/62 (6.5%)		1/20 (5%)		3/103 (2.9%)		3/205 (1.5%)		2/132 (1.5%)		3/153 (2%)
Musculoskeletal chest pain	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		16/184 (8.7%)		9/156 (5.8%)		9/168 (5.4%)		1/60 (1.7%)		1/90 (1.1%)		1/21 (4.8%)		1/18 (5.6%)		5/50 (10%)		4/51 (7.8%)		8/53 (15.1%)		0/44 (0%)		0/125 (0%)		3/62 (4.8%)		3/20 (15%)		5/103 (4.9%)		6/205 (2.9%)		1/132 (0.8%)		6/153 (3.9%)
Musculoskeletal pain	0/4 (0%)		0/13 (0%)		2/15 (13.3%)		0/21 (0%)		0/8 (0%)		18/184 (9.8%)		16/156 (10.3%)		13/168 (7.7%)		2/60 (3.3%)		1/90 (1.1%)		2/21 (9.5%)		0/18 (0%)		3/50 (6%)		4/51 (7.8%)		9/53 (17%)		8/44 (18.2%)		6/125 (4.8%)		10/62 (16.1%)		4/20 (20%)		3/103 (2.9%)		15/205 (7.3%)		2/132 (1.5%)		8/153 (5.2%)
Neck pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		1/8 (12.5%)		9/184 (4.9%)		7/156 (4.5%)		10/168 (6%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		2/53 (3.8%)		1/44 (2.3%)		4/125 (3.2%)		3/62 (4.8%)		1/20 (5%)		4/103 (3.9%)		8/205 (3.9%)		1/132 (0.8%)		14/153 (9.2%)
Bone pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		5/184 (2.7%)		7/156 (4.5%)		5/168 (3%)		1/60 (1.7%)		0/90 (0%)		1/21 (4.8%)		2/18 (11.1%)		2/50 (4%)		2/51 (3.9%)		2/53 (3.8%)		0/44 (0%)		2/125 (1.6%)		2/62 (3.2%)		0/20 (0%)		3/103 (2.9%)		2/205 (1%)		1/132 (0.8%)		3/153 (2%)
Groin pain	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		3/168 (1.8%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		8/205 (3.9%)		0/132 (0%)		2/153 (1.3%)
Myositis	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Trigger finger	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Arthritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		3/125 (2.4%)		3/62 (4.8%)		0/20 (0%)		2/103 (1.9%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Joint swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Bursitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Muscle oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Muscle twitching	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pathological fracture	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Plantar fasciitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Spinal osteoarthritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Spinal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		2/50 (4%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		1/153 (0.7%)
Tendonitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Musculoskeletal stiffness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		4/156 (2.6%)		1/168 (0.6%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		3/153 (2%)
Pain in jaw	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		7/153 (4.6%)
Rotator cuff syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypercreatinaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Intervertebral disc protrusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Joint range of motion decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Kyphosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Osteoarthritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Osteoporosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Periarthritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Polymyalgia rheumatica	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Soft tissue swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Musculoskeletal discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Coccydynia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Joint lock	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Muscle atrophy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Rheumatoid arthritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tendon disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tenosynovitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Joint stiffness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Finger deformity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Soft tissue necrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Autoimmune myositis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Clubbing	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Joint effusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Limb discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Joint instability	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Limb mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bone cyst	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Crystal arthropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Musculoskeletal disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Patellofemoral pain syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sjogren's syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Fracture pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Intervertebral disc degeneration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Muscle tightness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Polyarthritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Myosclerosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Osteonecrosis of jaw	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Trismus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Bone fistula	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Mobility decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Torticollis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		5/205 (2.4%)		1/132 (0.8%)		4/153 (2.6%)
Basal cell carcinoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		2/153 (1.3%)
Metastases to central nervous system	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Colon adenoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eye naevus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gastrointestinal tract adenoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nasal cavity cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Skin papilloma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Squamous cell carcinoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tumour flare	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Breast cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cancer pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		6/168 (3.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		3/153 (2%)
Hair follicle tumour benign	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haemangioma of bone	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastases to lymph nodes	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastases to skin	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tumour invasion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hepatic cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Malignant ascites	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Oesophageal squamous cell carcinoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Adrenocortical carcinoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haemangioma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tumour haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Malignant pleural effusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Metastases to breast	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastases to liver	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastases to muscle	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Metastatic malignant melanoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tumour associated fever	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Tumour ulceration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Seborrhoeic keratosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Squamous cell carcinoma of skin	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Acrochordon	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Melanocytic naevus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Myelodysplastic syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Neoplasm malignant	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Neoplasm swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Prostate cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Benign neoplasm of thyroid gland	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Bladder transitional cell carcinoma stage 0	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Metastases to bone	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Metastases to spine	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pancreatic neoplasm	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Transitional cell carcinoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urethral cancer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urinary tract carcinoma in situ	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Tumour fistulisation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Basosquamous carcinoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Peritumoural oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Schwannoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Nervous system disorders
Headache	0/4 (0%)		2/13 (15.4%)		1/15 (6.7%)		3/21 (14.3%)		1/8 (12.5%)		27/184 (14.7%)		27/156 (17.3%)		15/168 (8.9%)		2/60 (3.3%)		8/90 (8.9%)		1/21 (4.8%)		1/18 (5.6%)		6/50 (12%)		5/51 (9.8%)		4/53 (7.5%)		4/44 (9.1%)		16/125 (12.8%)		9/62 (14.5%)		4/20 (20%)		6/103 (5.8%)		16/205 (7.8%)		8/132 (6.1%)		17/153 (11.1%)
Dizziness	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		1/8 (12.5%)		22/184 (12%)		17/156 (10.9%)		11/168 (6.5%)		5/60 (8.3%)		7/90 (7.8%)		2/21 (9.5%)		1/18 (5.6%)		4/50 (8%)		4/51 (7.8%)		5/53 (9.4%)		4/44 (9.1%)		9/125 (7.2%)		5/62 (8.1%)		3/20 (15%)		12/103 (11.7%)		12/205 (5.9%)		5/132 (3.8%)		13/153 (8.5%)
Lethargy	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		5/168 (3%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Paraesthesia	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		2/156 (1.3%)		3/168 (1.8%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		2/125 (1.6%)		3/62 (4.8%)		1/20 (5%)		2/103 (1.9%)		3/205 (1.5%)		1/132 (0.8%)		4/153 (2.6%)
Dysgeusia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		5/156 (3.2%)		4/168 (2.4%)		3/60 (5%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		5/51 (9.8%)		1/53 (1.9%)		1/44 (2.3%)		2/125 (1.6%)		4/62 (6.5%)		1/20 (5%)		2/103 (1.9%)		4/205 (2%)		1/132 (0.8%)		2/153 (1.3%)
Hypoaesthesia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		1/156 (0.6%)		3/168 (1.8%)		2/60 (3.3%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		2/53 (3.8%)		0/44 (0%)		3/125 (2.4%)		2/62 (3.2%)		1/20 (5%)		4/103 (3.9%)		3/205 (1.5%)		0/132 (0%)		3/153 (2%)
Neuralgia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		1/132 (0.8%)		1/153 (0.7%)
Somnolence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		3/156 (1.9%)		1/168 (0.6%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		3/51 (5.9%)		1/53 (1.9%)		3/44 (6.8%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Dysarthria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Memory impairment	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		3/156 (1.9%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Peripheral sensory neuropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		4/156 (2.6%)		2/168 (1.2%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		1/18 (5.6%)		1/50 (2%)		2/51 (3.9%)		1/53 (1.9%)		1/44 (2.3%)		4/125 (3.2%)		0/62 (0%)		3/20 (15%)		3/103 (2.9%)		5/205 (2.4%)		4/132 (3%)		2/153 (1.3%)
Restless legs syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		3/125 (2.4%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Syncope	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		2/132 (1.5%)		2/153 (1.3%)
Vasogenic cerebral oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Balance disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		1/168 (0.6%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		0/132 (0%)		1/153 (0.7%)
Migraine	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Monoparesis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Radiculopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tremor	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		4/156 (2.6%)		2/168 (1.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		1/44 (2.3%)		4/125 (3.2%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		2/205 (1%)		1/132 (0.8%)		1/153 (0.7%)
Aphasia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Carotid artery stenosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Depressed level of consciousness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Disturbance in attention	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dizziness postural	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Facial paresis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hemiparesis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Horner's syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Neuropathy peripheral	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		2/168 (1.2%)		2/60 (3.3%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		3/153 (2%)
Parosmia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peripheral sensorimotor neuropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Phantom limb syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Seizure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Spinal cord compression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sciatica	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		3/156 (1.9%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		1/20 (5%)		1/103 (1%)		6/205 (2.9%)		1/132 (0.8%)		3/153 (2%)
Ataxia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Burning sensation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Cerebral infarction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cerebrovascular accident	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Cognitive disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hepatic encephalopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hypersomnia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypoxic-ischaemic encephalopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Intracranial aneurysm	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Monoplegia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nerve compression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Parkinson's disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Presyncope	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Psychomotor skills impaired	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sinus headache	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Subarachnoid haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Taste disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		1/44 (2.3%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Hyperaesthesia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		4/168 (2.4%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Myoclonus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Psychomotor hyperactivity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Tongue paralysis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ageusia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peripheral motor neuropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		2/132 (1.5%)		1/153 (0.7%)
Dyskinesia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hemianopia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Akathisia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Asterixis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dysaesthesia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Encephalopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Facial paralysis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Motor dysfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Muscle spasticity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Polyneuropathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Carpal tunnel syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Speech disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Febrile convulsion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Narcolepsy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sensory disturbance	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Altered state of consciousness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Amnesia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		4/205 (2%)		0/132 (0%)		0/153 (0%)
Apraxia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Coma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Coordination abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Resting tremor	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Sensory loss	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hypotonia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Aphonia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Brain oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Carotid sinus syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Metabolic encephalopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Pachymeningitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Unresponsive to stimuli	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Product Issues
Device occlusion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Device leakage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Device malfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Thrombosis in device	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Device breakage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Device dislocation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Device material opacification	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Psychiatric disorders
Insomnia	1/4 (25%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		14/184 (7.6%)		13/156 (8.3%)		13/168 (7.7%)		5/60 (8.3%)		8/90 (8.9%)		0/21 (0%)		1/18 (5.6%)		4/50 (8%)		5/51 (9.8%)		6/53 (11.3%)		2/44 (4.5%)		12/125 (9.6%)		3/62 (4.8%)		3/20 (15%)		6/103 (5.8%)		17/205 (8.3%)		13/132 (9.8%)		5/153 (3.3%)
Anxiety	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		27/184 (14.7%)		11/156 (7.1%)		11/168 (6.5%)		5/60 (8.3%)		4/90 (4.4%)		0/21 (0%)		1/18 (5.6%)		2/50 (4%)		2/51 (3.9%)		3/53 (5.7%)		5/44 (11.4%)		6/125 (4.8%)		2/62 (3.2%)		1/20 (5%)		8/103 (7.8%)		17/205 (8.3%)		3/132 (2.3%)		7/153 (4.6%)
Hallucination	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Restlessness	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Confusional state	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		8/184 (4.3%)		5/156 (3.2%)		3/168 (1.8%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		2/125 (1.6%)		1/62 (1.6%)		1/20 (5%)		2/103 (1.9%)		11/205 (5.4%)		1/132 (0.8%)		6/153 (3.9%)
Depression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		8/156 (5.1%)		1/168 (0.6%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		2/53 (3.8%)		2/44 (4.5%)		2/125 (1.6%)		2/62 (3.2%)		0/20 (0%)		2/103 (1.9%)		8/205 (3.9%)		2/132 (1.5%)		5/153 (3.3%)
Depressive symptom	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Agitation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		4/205 (2%)		1/132 (0.8%)		2/153 (1.3%)
Irritability	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Major depression	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Delirium	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Depressed mood	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Mood altered	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Sleep disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Mental status changes	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Anxiety disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Apathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bipolar disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Stress	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Libido decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Emotional distress	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nightmare	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Adjustment disorder with mixed anxiety and depressed mood	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hallucination, visual	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Panic attack	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Substance-induced psychotic disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Affective disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Personality change	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mood swings	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Mental disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Disorientation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Panic disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Affect lability	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Renal and urinary disorders
Proteinuria	0/4 (0%)		2/13 (15.4%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		4/156 (2.6%)		3/168 (1.8%)		0/60 (0%)		2/90 (2.2%)		2/21 (9.5%)		0/18 (0%)		5/50 (10%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		3/125 (2.4%)		3/62 (4.8%)		1/20 (5%)		2/103 (1.9%)		4/205 (2%)		1/132 (0.8%)		0/153 (0%)
Dysuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		6/184 (3.3%)		5/156 (3.2%)		2/168 (1.2%)		0/60 (0%)		3/90 (3.3%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		2/51 (3.9%)		0/53 (0%)		2/44 (4.5%)		5/125 (4%)		4/62 (6.5%)		0/20 (0%)		0/103 (0%)		11/205 (5.4%)		2/132 (1.5%)		1/153 (0.7%)
Haemoglobinuria	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pollakiuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		3/184 (1.6%)		2/156 (1.3%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		1/51 (2%)		2/53 (3.8%)		2/44 (4.5%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		7/205 (3.4%)		0/132 (0%)		2/153 (1.3%)
Haematuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		10/156 (6.4%)		2/168 (1.2%)		0/60 (0%)		2/90 (2.2%)		1/21 (4.8%)		0/18 (0%)		3/50 (6%)		3/51 (5.9%)		3/53 (5.7%)		2/44 (4.5%)		1/125 (0.8%)		3/62 (4.8%)		2/20 (10%)		1/103 (1%)		17/205 (8.3%)		1/132 (0.8%)		1/153 (0.7%)
Acute kidney injury	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		5/156 (3.2%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		2/44 (4.5%)		1/125 (0.8%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		10/205 (4.9%)		4/132 (3%)		0/153 (0%)
Nocturia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		2/153 (1.3%)
Urinary retention	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		3/156 (1.9%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		5/205 (2.4%)		1/132 (0.8%)		0/153 (0%)
Azotaemia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chromaturia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Costovertebral angle tenderness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hydronephrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		6/103 (5.8%)		6/205 (2.9%)		1/132 (0.8%)		0/153 (0%)
Nephrolithiasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Renal infarct	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urinary tract pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urine odour abnormal	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urinary incontinence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		3/156 (1.9%)		3/168 (1.8%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		6/205 (2.9%)		1/132 (0.8%)		0/153 (0%)
Micturition urgency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		3/156 (1.9%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Bladder spasm	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		5/205 (2.4%)		0/132 (0%)		0/153 (0%)
Calculus urinary	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Chronic kidney disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		3/132 (2.3%)		1/153 (0.7%)
Leukocyturia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urethral disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Urine flow decreased	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Incontinence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Stress urinary incontinence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypertonic bladder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Renal failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		2/44 (4.5%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		6/205 (2.9%)		0/132 (0%)		0/153 (0%)
Urinary tract obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		1/21 (4.8%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		4/205 (2%)		1/132 (0.8%)		0/153 (0%)
Renal colic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Polyuria	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Renal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bladder dilatation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bladder trabeculation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nephritis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Cystitis noninfective	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Urinary hesitation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bladder pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Ureteric obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urethral stenosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urge incontinence	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Urine abnormality	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Vaginal haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ejaculation disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Reproductive system and breast disorders
Adnexa uteri mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Breast tenderness	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pelvic discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Postmenopausal haemorrhage	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vaginal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		4/205 (2%)		0/132 (0%)		0/153 (0%)
Pelvic pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		1/21 (4.8%)		1/18 (5.6%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		3/44 (6.8%)		1/125 (0.8%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		5/205 (2.4%)		1/132 (0.8%)		0/153 (0%)
Benign prostatic hyperplasia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Breast mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Breast haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Breast swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Erectile dysfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Genital rash	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nipple pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Scrotal oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Scrotal swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Testicular oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vaginal discharge	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		1/132 (0.8%)		0/153 (0%)
Vulvovaginal pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		3/62 (4.8%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Genital discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Prostatomegaly	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vulvovaginal dryness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vulvovaginal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Gynaecomastia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Metrorrhagia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Breast pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dyspareunia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Haematospermia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Prostatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Varicocele	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oedema genital	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Penile swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Testicular pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Uterine atrophy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sexual dysfunction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Scrotal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Menopausal symptoms	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/4 (0%)		1/13 (7.7%)		3/15 (20%)		3/21 (14.3%)		1/8 (12.5%)		51/184 (27.7%)		26/156 (16.7%)		23/168 (13.7%)		5/60 (8.3%)		11/90 (12.2%)		1/21 (4.8%)		3/18 (16.7%)		15/50 (30%)		11/51 (21.6%)		20/53 (37.7%)		5/44 (11.4%)		9/125 (7.2%)		22/62 (35.5%)		3/20 (15%)		9/103 (8.7%)		37/205 (18%)		14/132 (10.6%)		13/153 (8.5%)
Rhinitis allergic	0/4 (0%)		2/13 (15.4%)		1/15 (6.7%)		2/21 (9.5%)		0/8 (0%)		3/184 (1.6%)		5/156 (3.2%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		3/125 (2.4%)		2/62 (3.2%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Dyspnoea	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		1/21 (4.8%)		0/8 (0%)		26/184 (14.1%)		33/156 (21.2%)		19/168 (11.3%)		6/60 (10%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		12/50 (24%)		7/51 (13.7%)		14/53 (26.4%)		9/44 (20.5%)		13/125 (10.4%)		14/62 (22.6%)		8/20 (40%)		21/103 (20.4%)		33/205 (16.1%)		10/132 (7.6%)		16/153 (10.5%)
Dyspnoea exertional	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		2/21 (9.5%)		0/8 (0%)		25/184 (13.6%)		12/156 (7.7%)		24/168 (14.3%)		1/60 (1.7%)		4/90 (4.4%)		1/21 (4.8%)		0/18 (0%)		8/50 (16%)		4/51 (7.8%)		5/53 (9.4%)		3/44 (6.8%)		8/125 (6.4%)		3/62 (4.8%)		2/20 (10%)		0/103 (0%)		7/205 (3.4%)		3/132 (2.3%)		2/153 (1.3%)
Productive cough	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		2/21 (9.5%)		0/8 (0%)		13/184 (7.1%)		11/156 (7.1%)		4/168 (2.4%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		4/50 (8%)		0/51 (0%)		5/53 (9.4%)		3/44 (6.8%)		2/125 (1.6%)		5/62 (8.1%)		3/20 (15%)		2/103 (1.9%)		9/205 (4.4%)		1/132 (0.8%)		13/153 (8.5%)
Wheezing	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		2/21 (9.5%)		0/8 (0%)		8/184 (4.3%)		4/156 (2.6%)		6/168 (3.6%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		4/20 (20%)		3/103 (2.9%)		3/205 (1.5%)		2/132 (1.5%)		2/153 (1.3%)
Pleural effusion	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		1/21 (4.8%)		0/8 (0%)		7/184 (3.8%)		4/156 (2.6%)		10/168 (6%)		2/60 (3.3%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		3/51 (5.9%)		5/53 (9.4%)		1/44 (2.3%)		5/125 (4%)		1/62 (1.6%)		2/20 (10%)		5/103 (4.9%)		8/205 (3.9%)		8/132 (6.1%)		3/153 (2%)
Upper-airway cough syndrome	0/4 (0%)		1/13 (7.7%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		7/184 (3.8%)		2/156 (1.3%)		2/168 (1.2%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		2/132 (1.5%)		4/153 (2.6%)
Atelectasis	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Dysphonia	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		6/184 (3.3%)		5/156 (3.2%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		1/21 (4.8%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		4/62 (6.5%)		0/20 (0%)		2/103 (1.9%)		2/205 (1%)		1/132 (0.8%)		5/153 (3.3%)
Epistaxis	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		3/125 (2.4%)		2/62 (3.2%)		0/20 (0%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		5/153 (3.3%)
Nasal congestion	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		12/184 (6.5%)		7/156 (4.5%)		5/168 (3%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		1/18 (5.6%)		2/50 (4%)		1/51 (2%)		2/53 (3.8%)		0/44 (0%)		4/125 (3.2%)		2/62 (3.2%)		1/20 (5%)		4/103 (3.9%)		2/205 (1%)		2/132 (1.5%)		3/153 (2%)
Oropharyngeal pain	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		9/184 (4.9%)		8/156 (5.1%)		7/168 (4.2%)		2/60 (3.3%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		0/53 (0%)		2/44 (4.5%)		4/125 (3.2%)		3/62 (4.8%)		1/20 (5%)		9/103 (8.7%)		7/205 (3.4%)		2/132 (1.5%)		5/153 (3.3%)
Pleuritic pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		2/184 (1.1%)		4/156 (2.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Pulmonary embolism	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		5/156 (3.2%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		6/205 (2.9%)		3/132 (2.3%)		0/153 (0%)
Respiratory symptom	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hiccups	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		1/60 (1.7%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		3/132 (2.3%)		0/153 (0%)
Haemoptysis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		16/184 (8.7%)		10/156 (6.4%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		3/53 (5.7%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		5/205 (2.4%)		2/132 (1.5%)		11/153 (7.2%)
Chronic obstructive pulmonary disease	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		8/184 (4.3%)		4/156 (2.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		3/205 (1.5%)		0/132 (0%)		2/153 (1.3%)
Hypoxia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		6/184 (3.3%)		4/156 (2.6%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		2/53 (3.8%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		4/205 (2%)		1/132 (0.8%)		6/153 (3.9%)
Pneumonitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		5/156 (3.2%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		2/51 (3.9%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		2/62 (3.2%)		3/20 (15%)		0/103 (0%)		6/205 (2.9%)		2/132 (1.5%)		4/153 (2.6%)
Rhinorrhoea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		5/156 (3.2%)		4/168 (2.4%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		1/53 (1.9%)		1/44 (2.3%)		0/125 (0%)		2/62 (3.2%)		1/20 (5%)		1/103 (1%)		6/205 (2.9%)		0/132 (0%)		2/153 (1.3%)
Pneumothorax	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		3/156 (1.9%)		2/168 (1.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		2/153 (1.3%)
Respiratory tract congestion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Allergic sinusitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Emphysema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lung infiltration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Nasal dryness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Orthopnoea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary congestion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Pulmonary fibrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary venous thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Respiratory distress	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Sinus congestion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		2/53 (3.8%)		0/44 (0%)		3/125 (2.4%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Tachypnoea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Throat irritation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Throat tightness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Hypercapnia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bronchial obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Bronchitis chronic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lower respiratory tract congestion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Paranasal sinus hypersecretion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Rhonchi	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Tracheal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hydrothorax	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Paranasal sinus discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Pleurisy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Rales	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Sputum discoloured	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Stridor	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pneumonia aspiration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Aspiration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		3/153 (2%)
Asthma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Laryngeal haemorrhage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Respiratory tract inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Bronchopneumopathy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Bronchospasm	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypopnoea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lung disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		2/44 (4.5%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oropharyngeal plaque	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Sneezing	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary hypertension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dyspnoea at rest	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pharyngeal swelling	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pulmonary pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Acute respiratory distress syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nasal inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Allergic pharyngitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Oropharyngeal discomfort	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Painful respiration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Respiratory acidosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Respiratory failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Rhinalgia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Acute respiratory failure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Laryngeal inflammation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Obstructive airways disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Pulmonary mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Upper respiratory tract congestion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Upper respiratory tract irritation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Chylothorax	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hyperventilation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Choking	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Increased viscosity of bronchial secretion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Laryngeal obstruction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Laryngeal pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Pharyngeal erythema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Pharyngeal oedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Skin and subcutaneous tissue disorders
Rash	1/4 (25%)		1/13 (7.7%)		2/15 (13.3%)		2/21 (9.5%)		2/8 (25%)		12/184 (6.5%)		17/156 (10.9%)		7/168 (4.2%)		2/60 (3.3%)		11/90 (12.2%)		0/21 (0%)		1/18 (5.6%)		10/50 (20%)		4/51 (7.8%)		5/53 (9.4%)		4/44 (9.1%)		13/125 (10.4%)		11/62 (17.7%)		1/20 (5%)		6/103 (5.8%)		23/205 (11.2%)		6/132 (4.5%)		12/153 (7.8%)
Pruritus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		2/8 (25%)		10/184 (5.4%)		14/156 (9%)		9/168 (5.4%)		1/60 (1.7%)		14/90 (15.6%)		0/21 (0%)		0/18 (0%)		7/50 (14%)		6/51 (11.8%)		7/53 (13.2%)		6/44 (13.6%)		9/125 (7.2%)		15/62 (24.2%)		0/20 (0%)		6/103 (5.8%)		27/205 (13.2%)		8/132 (6.1%)		18/153 (11.8%)
Urticaria	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		1/8 (12.5%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		2/103 (1.9%)		4/205 (2%)		1/132 (0.8%)		0/153 (0%)
Dermatitis acneiform	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		0/51 (0%)		1/53 (1.9%)		1/44 (2.3%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rash maculo-papular	0/4 (0%)		0/13 (0%)		0/15 (0%)		1/21 (4.8%)		0/8 (0%)		2/184 (1.1%)		5/156 (3.2%)		5/168 (3%)		3/60 (5%)		3/90 (3.3%)		2/21 (9.5%)		2/18 (11.1%)		4/50 (8%)		2/51 (3.9%)		1/53 (1.9%)		5/44 (11.4%)		9/125 (7.2%)		2/62 (3.2%)		2/20 (10%)		1/103 (1%)		8/205 (3.9%)		2/132 (1.5%)		2/153 (1.3%)
Rash pruritic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		5/184 (2.7%)		2/156 (1.3%)		2/168 (1.2%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		2/51 (3.9%)		0/53 (0%)		2/44 (4.5%)		2/125 (1.6%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		4/205 (2%)		1/132 (0.8%)		1/153 (0.7%)
Rash vesicular	1/4 (25%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin hyperpigmentation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		1/8 (12.5%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Night sweats	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		11/184 (6%)		5/156 (3.2%)		1/168 (0.6%)		1/60 (1.7%)		0/90 (0%)		1/21 (4.8%)		0/18 (0%)		2/50 (4%)		2/51 (3.9%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		2/103 (1.9%)		7/205 (3.4%)		4/132 (3%)		6/153 (3.9%)
Erythema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		8/184 (4.3%)		1/156 (0.6%)		6/168 (3.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		3/51 (5.9%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		4/62 (6.5%)		0/20 (0%)		4/103 (3.9%)		4/205 (2%)		0/132 (0%)		6/153 (3.9%)
Dry skin	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		14/156 (9%)		8/168 (4.8%)		0/60 (0%)		4/90 (4.4%)		0/21 (0%)		1/18 (5.6%)		4/50 (8%)		2/51 (3.9%)		3/53 (5.7%)		3/44 (6.8%)		3/125 (2.4%)		9/62 (14.5%)		1/20 (5%)		1/103 (1%)		14/205 (6.8%)		3/132 (2.3%)		8/153 (5.2%)
Hyperhidrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		5/184 (2.7%)		4/156 (2.6%)		4/168 (2.4%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		4/53 (7.5%)		0/44 (0%)		1/125 (0.8%)		2/62 (3.2%)		0/20 (0%)		5/103 (4.9%)		3/205 (1.5%)		2/132 (1.5%)		1/153 (0.7%)
Dermatitis contact	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		2/50 (4%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin lesion	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		3/153 (2%)
Dermatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Pain of skin	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Psoriasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		2/153 (1.3%)
Rash generalised	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		0/156 (0%)		3/168 (1.8%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Acne	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Actinic keratosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		1/20 (5%)		1/103 (1%)		3/205 (1.5%)		0/132 (0%)		0/153 (0%)
Alopecia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		6/156 (3.8%)		3/168 (1.8%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		2/44 (4.5%)		4/125 (3.2%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		4/205 (2%)		0/132 (0%)		0/153 (0%)
Anhidrosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Decubitus ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		1/132 (0.8%)		0/153 (0%)
Dermatitis exfoliative generalised	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Eczema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		2/53 (3.8%)		0/44 (0%)		3/125 (2.4%)		3/62 (4.8%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		2/132 (1.5%)		2/153 (1.3%)
Haemorrhage subcutaneous	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ingrowing nail	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Onycholysis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Paraneoplastic rash	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pigmentation disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pruritus generalised	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		4/156 (2.6%)		4/168 (2.4%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin exfoliation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Skin irritation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Skin mass	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		1/132 (0.8%)		1/153 (0.7%)
Skin ulcer	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		3/156 (1.9%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Hyperkeratosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		3/156 (1.9%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Rash macular	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		1/153 (0.7%)
Photosensitivity reaction	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Purpura	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		2/156 (1.3%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Blister	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hand dermatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lichen planus	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nail discolouration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Papule	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Petechiae	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Rash papular	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Skin discolouration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Angioedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ecchymosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Facial wasting	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nail disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pemphigoid	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin hypopigmentation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Rash erythematous	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		2/90 (2.2%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		1/153 (0.7%)
Rosacea	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		2/60 (3.3%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Cold sweat	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Dermatitis bullous	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypertrichosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Palmar-plantar erythrodysaesthesia syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Seborrhoeic dermatitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Dermatosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin burning sensation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vitiligo	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Macule	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nail toxicity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Erythema ab igne	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lichenoid keratosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Melanocytic hyperplasia	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Scar pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Diabetic foot	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nail dystrophy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nail pigmentation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Nail ridging	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		1/20 (5%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Skin induration	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Skin toxicity	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Idiopathic guttate hypomelanosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Onychomadesis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Erythema multiforme	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Granuloma skin	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Skin fissures	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Xeroderma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Blood blister	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Drug eruption	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Skin disorder	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Skin hypertrophy	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Swelling face	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Solar lentigo	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Actinic cheilitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Dermatitis allergic	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Madarosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Nodular rash	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Onychoclasis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Social circumstances
Loss of personal independence in daily activities	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pregnancy of partner	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Surgical and medical procedures
Dental implantation	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Manual lymphatic drainage	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Therapeutic procedure	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Infection prophylaxis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Vascular disorders
Hypertension	0/4 (0%)		1/13 (7.7%)		3/15 (20%)		3/21 (14.3%)		1/8 (12.5%)		8/184 (4.3%)		26/156 (16.7%)		12/168 (7.1%)		2/60 (3.3%)		5/90 (5.6%)		1/21 (4.8%)		0/18 (0%)		12/50 (24%)		5/51 (9.8%)		6/53 (11.3%)		4/44 (9.1%)		13/125 (10.4%)		6/62 (9.7%)		4/20 (20%)		11/103 (10.7%)		30/205 (14.6%)		9/132 (6.8%)		19/153 (12.4%)
Hypotension	0/4 (0%)		0/13 (0%)		0/15 (0%)		3/21 (14.3%)		0/8 (0%)		9/184 (4.9%)		6/156 (3.8%)		3/168 (1.8%)		2/60 (3.3%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		3/50 (6%)		1/51 (2%)		4/53 (7.5%)		5/44 (11.4%)		4/125 (3.2%)		3/62 (4.8%)		0/20 (0%)		3/103 (2.9%)		6/205 (2.9%)		5/132 (3.8%)		4/153 (2.6%)
Embolism	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Flushing	0/4 (0%)		1/13 (7.7%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		3/184 (1.6%)		3/156 (1.9%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Vena cava thrombosis	0/4 (0%)		0/13 (0%)		1/15 (6.7%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Hot flush	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		8/184 (4.3%)		7/156 (4.5%)		5/168 (3%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		6/125 (4.8%)		2/62 (3.2%)		0/20 (0%)		3/103 (2.9%)		4/205 (2%)		3/132 (2.3%)		2/153 (1.3%)
Deep vein thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		4/184 (2.2%)		4/156 (2.6%)		2/168 (1.2%)		0/60 (0%)		1/90 (1.1%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		2/62 (3.2%)		0/20 (0%)		1/103 (1%)		2/205 (1%)		2/132 (1.5%)		1/153 (0.7%)
Haematoma	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		2/184 (1.1%)		2/156 (1.3%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Arterial thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Ischaemic limb pain	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Jugular vein thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		1/156 (0.6%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Orthostatic hypotension	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		2/103 (1.9%)		0/205 (0%)		0/132 (0%)		2/153 (1.3%)
Venous thrombosis limb	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		1/156 (0.6%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Lymphoedema	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		2/168 (1.2%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		2/125 (1.6%)		1/62 (1.6%)		0/20 (0%)		3/103 (2.9%)		2/205 (1%)		0/132 (0%)		0/153 (0%)
Peripheral embolism	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		1/168 (0.6%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Brachiocephalic vein thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		1/60 (1.7%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Subclavian vein thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		1/153 (0.7%)
Thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		1/184 (0.5%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		1/125 (0.8%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Aortitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		1/50 (2%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Hypovolaemic shock	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Peripheral coldness	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		1/51 (2%)		1/53 (1.9%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pallor	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Phlebitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		1/44 (2.3%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Thrombophlebitis superficial	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		1/62 (1.6%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Pelvic venous thrombosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Phlebitis superficial	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Raynaud's phenomenon	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		1/103 (1%)		0/205 (0%)		0/132 (0%)		0/153 (0%)
Arteriosclerosis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Hypertensive urgency	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		1/205 (0.5%)		0/132 (0%)		0/153 (0%)
Vasculitis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		1/132 (0.8%)		0/153 (0%)
Hypertensive crisis	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Superior vena cava syndrome	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)
Varicose vein	0/4 (0%)		0/13 (0%)		0/15 (0%)		0/21 (0%)		0/8 (0%)		0/184 (0%)		0/156 (0%)		0/168 (0%)		0/60 (0%)		0/90 (0%)		0/21 (0%)		0/18 (0%)		0/50 (0%)		0/51 (0%)		0/53 (0%)		0/44 (0%)		0/125 (0%)		0/62 (0%)		0/20 (0%)		0/103 (0%)		0/205 (0%)		0/132 (0%)		1/153 (0.7%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.