Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck

• Sponsor: AstraZeneca (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02499328
• Collaborator: MedImmune LLC (Industry)
• Enrollment: 340
• Locations: 43
• Arms: 15
• Anticipated Duration (Months): 85.6
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a dose-escalation, safety run-in Part A and a dose-expansion Part B

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck	Drug: AZD9150; Drug: MEDI4736; Drug: AZD5069; Drug: tremelimumab (treme)	Phase 1/Phase 2

Detailed Description

The dose-escalation Part A of this study will involve patients with advanced solid malignancies refractory to standard therapy or for which no standard of care regimen currently exists. Approximately 30 evaluable patients per treatment arm (A1 or A2) will be enrolled. A3 will test viability of alternate dosing schedule for AZD5069, A4/A5 will evaluate AZD9150/AZD5069 in fixed dose combination with MEDI4736 and tremelimumab in solid tumors. there may also be safety run in cohorts enrolled (A6/A7) in specific solid tumor types (breast and prostate cancer).

Once the maximum tolerated doses (MTDs) for each of the 2 agents (AZD9150/AZD5069)in combination with MEDI4736 have been identified or the maximum doses of each of the 2 agents in combination with MEDI4736 have been reached, the dose expansion Part B of the study would commence. It will be conducted in patients with recurrent and/or metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN). Between 68 and 266 eligible patients will be enrolled and will randomly assigned to 1 of the following 6 treatment arms or non randomized arm B7:

• Treatment arm B1: AZD9150 in combination with MEDI4736 in patients with prior exposure to anti-PD-(L)1 antibodies

• Treatment arm B2: AZD5069 in combination with MEDI4736 in patients with prior exposure to anti-PD-(L)1 antibodies

• Treatment arm B3: AZD9150 in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies (2L RM SCCHN)

• Treatment arm B4: AZD5069 in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies

• Treatment arm B5: AZD9150 alone in patients with no prior exposure to anti-PD-(L)1 antibodies

• Treatment arm B6: AZD5069 alone in patients with no prior exposure to anti-PD-(L)1 antibodies

• Treatment arm B7: (non randomized): AZD9150 in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies (1L RM SCCHN)

• Treatment arm B8: (non randomized): AZD9150 (every two weeks) in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies (1L RM SCCHN)

Study Design

• Study Type: Interventional
• Actual Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
• Actual Study Start Date: Aug 5, 2015
• Actual Primary Completion Date: Feb 28, 2020
• Anticipated Study Completion Date: Sep 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A1: AZD9150 / MEDI4736 Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Drug: AZD9150; AZD9150; Drug: MEDI4736; MEDI4736
Experimental: Part A2: AZD5069 / MEDI4736 Patients allocated in cohort of arm A2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B1:AZD9150+MEDI4736:PDL1 pretreated Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: AZD9150; AZD9150; Drug: MEDI4736; MEDI4736
Experimental: Part B2:AZD5069+MEDI4736:PDL1 pretreated Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B3: AZD9150+MED4736:naiive 2L Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: AZD9150; AZD9150; Drug: MEDI4736; MEDI4736
Experimental: Part B4:AZD5069+MEDI4736:naiive patients Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B5: AZD9150 in naiive patients Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Drug: AZD9150; AZD9150
Experimental: Part B6:AZD5069 in naiive patients Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Drug: AZD5069; AZD5069
Experimental: Part A3: AZD5069/MEDI4736 Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part A4: AZD9150/Treme/MEDI4736 Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Drug: AZD9150; AZD9150; Drug: MEDI4736; MEDI4736; Drug: tremelimumab (treme); tremelimumab
Experimental: Part A5: AZD5069/Treme/MEDI4736 Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069; Drug: tremelimumab (treme); tremelimumab
Experimental: Part A6: AZD9150/MEDI4736 Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Drug: AZD9150; AZD9150; Drug: MEDI4736; MEDI4736
Experimental: Part A7: AZD5069/MEDI4736 Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B7: AZD9150+MEDI4736: naiive 1L Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Drug: AZD9150; AZD9150; Drug: MEDI4736; MEDI4736
Experimental: Part B8: AZD9150 (every other week)+MEDI4736: naive 1L Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Drug: AZD9150; AZD9150; Drug: MEDI4736; MEDI4736

Outcome Measures

Primary Outcome Measures

1. Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion [35 days]

   After completion of DLT period (35 days) for the maximum dose cohort. A CRM-based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the "model estimated" MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.

2. Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion [35 days]

   After completion of DLT period (35 days) for the maximum dose cohort. A CRM-based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the "model estimated" MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.

3. Part A: Safety and Tolerability in Terms of Adverse Events [At every treatment and follow up visit until disease progression, an average of 1 year.]

   Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

4. Part B: ORR (Objective Response Rate) in Patients With IL/2L RM-SCCHN. [Assessed at every even-numbered cycles with RECIST until disease progression, up to 12 months.]

   proportion of patients who have an objective response at a given visit. ORR will be summarised by treatment group. Objective rate is defined as a CR or PR according to RECIST 1.1.

Secondary Outcome Measures

1. Part A and B: AZD9150 AUC0-6h at Lead in Day-7 [Lead in day -7, AUC from time 0 to 6h (post dose).]

   If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.

2. Part A and B: AZD9150 Cmax at Lead in Day -7 [Lead in day -7]

   If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.

3. Part A and B: AZD9150 AUC0-6h at Cycle 2 Day 1 [Cycle 2 day 1, AUC from time 0 to 6 h post dose]

   If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.

4. Part A and B: AZD9150 Cmax at Cycle 2 Day 1 [Cycle 2 day 1]

5. Part A and B: AZD5069 AUC0-12h at Lead in Day -7 [Lead in day -7, AUC from time 0 to 12h post dose]

   If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.

6. Part A and B: AZD5069 Cmax at Lead in Day -7 [Lead in day -7]

   If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.

7. Part A and B: AZD5069 Cssmax at Cycle 2 Day 1 [Cycle 2 day 1]

   If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at around Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.

8. Part A and B: AZD5069 AUCss at Cycle 2 Day 1 [Cycle 2 day 1]

   If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.

9. Part A and B: Durvalumab Cmax After Single Dose at Cycle 1 Day 1 [Cycle 1 day 1]

10. Part A and B: Durvalumab Ctrough After Multiple Doses at Cycle 4 Day 1 [Cycle 4 day 1]

    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.

11. Part A and B: Durvalumab Cmax After Multiple Doses at Cycle 8 Day 1 [Cycle 8 day 1]

    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.

12. Part A and B: Treme Cmax After Single Dose [Cycle 1 day 1]

    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.

13. Part A and B: Treme Ctrough After Multiple Doses at Cycle 4 Day 1 [Cycle 4 day 1]

    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.

14. Part A and B: Immunogenecity as Percent of ADA Positive Subjects [Throughout the study, up to 3.3 years]

    Subject was considered ADA positive if any post dose samples had ADA positive result. Result was not stratified based on post dose time points.

15. Part A: Antitumour Activity in Monotherapy and Combination Arms of Study [assessed at every even numbered cycle with RECIST until disease progression, an average of 1 year]

    complete response, partial response, stable disease or progressive disease based on RECIST

16. Part B: Safety and Tolerability in Terms of Adverse Events [At every treatment and follow up visit until disease progression, an average of 1 year.]

    Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

17. Part B: Secondary Measures Change in Efficacy - Disease Control Rate [Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months]

    Disease control rate is confirmed complete response (CR), confirmed partial response (PR) and stable disease (SD)

18. Part B: Secondary Measures Change in Efficacy - Duration of Overall Response [Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 48 months]

    Duration of overall response is according to RECIST 1.1 criteria measured from the time measurement criteria are first met for CR or PR, whichever is first recorded, until the first date that recurrent or PD is objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR is only applied to treatment groups where at least one response patient was recorded.

19. Part B: Secondary Measures Change in Efficacy - PFS [Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months]

    progression-free survival (PFS): defined as the time from randomisation to the first documentation of PD as determined by the Investigator or death from any cause, whichever occurs first. Only includes progression events that occur within 126 days of the last evaluable assessment

20. Part B: Secondary Measures Change in Efficacy - OS [Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 15 months]

    overall survival (OS) - defined as the time from treatment allocation to death from any cause

21. Part B: Secondary Measures Change in Efficacy - OS at 12 Months [Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months]

    proportion of patients alive at 12 months: the percentage of patients surviving at 12 months after randomization to study drug

22. Part B: Evaluation of AZD9150 Pharmacodynamics: Change in STAT3 RNA Level From Baseline [At Cycle 2 Day 1 vs. Baseline]

    Percent STAT3 RNA change in expression level in peripheral blood in patients who had baseline (Screening or Day -7) sample for comparison. Data were only available for B1, B3, B5, B7 and B8.

23. Part B: Evaluation of PDL1 Expression [in baseline tumor samples]

    Tumors with PDL1-positive tumor cells at the designated cutoff. Data were only available for B1, B2, B3, B4, B7 and B8.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 130 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Male and female patients must be at least 18 years of age.

• Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.

• Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases). Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy.

• Has undergone ≤3 previous regimens (depending on treatment arm) of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil. for B7 & B8, no prior systemic treatments should have been received for RM SCCHN

• Adequate organ and marrow function

• Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol

• Additional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.

• Addition inclusion for Part A (A6) Has a histological confirmation of castrate-resistant prostate cancer

• Additional inclusion for Part B:Has histologically and/or cytologically confirmed SCCHN that is RM and not amendable to curative therapy by surgery or radiation. Squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx. Has at least 1 SCCHN tumour lesion (TL) amenable to biopsy and must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for RM-SCCHN Additional inclusion criteria for Arms B1 & B2: must have had prior exposure to anti PDL-1 antibody

• Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies Arm B7 & B8: with no prior exposure to anti-PD-(L)1 therapies and have received no prior systemic treatment for RM SCCHN

Key Exclusion Criteria:

• Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are: Previously treated in-situ carcinoma (ie, noninvasive) Cervical carcinoma stage 1B or less Noninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy

• Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy [Chemotherapy washout within 21 days or 5 half-lives (whichever is shorter) from enrolment], radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable),

• Experiencing CTCAE grade >1 events, experienced immune-related grade ≥3AEs with prior immunotherapy

• Has active or prior autoimmune disease within the past 2 years

• Has active or prior inflammatory bowel disease or primary immunodeficiency

• Undergone an organ transplant that requires use of immunosuppressive treatment

• Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG

• uncontrolled comorbid conditions

• Received a live attenuated vaccine within 30 days of first study dose, unable to take oral medications

• History of allergic reactions to study compounds or excepients Additional exclusion criteria Part A: Patients with clinically active brain metastases and prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.

Additional exclusion criteria Part B: Patients with brain metastases (known or suspected) Additional exclusion criteria Part B: treatment arms B3, B4, B5, B6, B7 and B8: prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States	35294
2	Research Site	Duarte	California	United States	91010
3	Research Site	La Jolla	California	United States	92093
4	Research Site	Los Angeles	California	United States	90024
5	Research Site	Los Angeles	California	United States	90089
6	Research Site	Orange	California	United States	92868-3298
7	Research Site	San Francisco	California	United States	94158
8	Research Site	Denver	Colorado	United States	80218
9	Research Site	Plantation	Florida	United States	33324
10	Research Site	Sarasota	Florida	United States	34232
11	Research Site	Lafayette	Indiana	United States	47905
12	Research Site	Boston	Massachusetts	United States	02111
13	Research Site	Detroit	Michigan	United States	48201
14	Research Site	Billings	Montana	United States	59101
15	Research Site	Morristown	New Jersey	United States	07960
16	Research Site	Cincinnati	Ohio	United States	45267-2827
17	Research Site	Houston	Texas	United States	77030
18	Research Site	Fairfax	Virginia	United States	22031
19	Research Site	Seattle	Washington	United States	98109
20	Research Site	Antwerpen		Belgium	2020
21	Research Site	Brussels		Belgium	1000
22	Research Site	Bruxelles		Belgium	1200
23	Research Site	Edegem		Belgium	2650
24	Research Site	Namur		Belgium	5000
25	Research Site	Berlin		Germany	12200
26	Research Site	Dresden		Germany	1307
27	Research Site	Frankfurt		Germany	60488
28	Research Site	Hamburg		Germany	20246
29	Research Site	Hannover		Germany	30625
30	Research Site	Jena		Germany	07743
31	Research Site	Köln		Germany	50670
32	Research Site	München		Germany	81675
33	Research Site	Milano		Italy	20133
34	Research Site	Barcelona		Spain	08035
35	Research Site	Hospitalet deLlobregat		Spain	08907
36	Research Site	Madrid		Spain	28040
37	Research Site	Madrid		Spain	28041
38	Research Site	Toledo		Spain	45004
39	Research Site	Birmingham		United Kingdom	B15 2TH
40	Research Site	London		United Kingdom	SE1 9RT
41	Research Site	London		United Kingdom	SW3 6JB
42	Research Site	Manchester		United Kingdom	M20 4BX
43	Research Site	Taunton		United Kingdom	TA1 5DA

Sponsors and Collaborators

• AstraZeneca
• MedImmune LLC

Investigators

• Principal Investigator: Dr David Hong, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol - Nov 20, 2019
• Statistical Analysis Plan - Apr 8, 2020

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02499328
• Other Study ID Numbers: D5660C00004
• First Posted: Jul 16, 2015
• Last Update Posted: Feb 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AstraZeneca: Carcinoma of the Head and Neck
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Durvalumab; Tremelimumab

Study Results

Participant Flow

Arm/Group Title	A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg	A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg	A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg	A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg	A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg	A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp	B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp	B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive	B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive	B5: AZD9150 3mg/kg	B6: AZD5069 40mg BID	B6a: AZD5069 40mg BID Fed/Fasted	B6b: AZD5069 40mg BID Fasted/Fed	B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
Arm/Group Description	2mg/kg QW danvatirsen IV + 20mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	40mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab	80mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab	80 mg BID AZD5069 (PO) with scheduled dose holds and titrations + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab	2 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab	3 mg/kg Q2W danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV	40 mg BID AZD5069 (PO)	AZD5069 40mg BID (PO): Fed/Fasted	AZD5069 40mg BID (PO): Fasted/Fed	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	400 mg Q2W danvatirsen IV + 1.5 g Q4W durvalumab
Period Title: Overall Study
STARTED	4	7	10	11	15	9	7	6	14	24	20	54	25	17	10	1	1	55	50
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
NOT COMPLETED	4	7	10	11	15	9	7	6	14	24	20	54	25	17	10	1	1	55	49

Baseline Characteristics

Arm/Group Title	A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg	A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg	A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg	A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg	A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg	A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp	B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp	B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive	B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive	B5: AZD9150 3mg/kg	B6: AZD5069 40mg BID	B6a: AZD5069 40mg BID Fed/Fasted	B6b: AZD5069 40mg BID Fasted/Fed	B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W	Total
Arm/Group Description	2mg/kg QW danvatirsen IV + 20mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	40mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab	80mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab	80 mg BID AZD5069 (PO) with scheduled dose holds and titrations + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab	2 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab	3 mg/kg Q2W danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab	3 mg/kg QW danvatirsen IV	40 mg BID AZD5069 (PO)	AZD5069 40mg BID (PO): Fed/Fasted	AZD5069 40mg BID (PO): Fasted/Fed	3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab	400 mg Q2W danvatirsen IV + 1.5 g Q4W durvalumab	Total of all reporting groups
Overall Participants	4	7	9	11	15	9	7	6	14	24	20	53	22	14	10	1	1	55	50	332
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	55.8 (10.5)	64.1 (5.9)	55.3 (9.0)	64.5 (12.7)	59.7 (10.2)	53.4 (14.5)	57.0 (15.8)	54.0 (8.7)	69.3 (8.2)	65.5 (8.8)	64.8 (9.0)	61.5 (8.8)	61.1 (7.7)	60.6 (9.6)	61.4 (9.2)	64.0 (NA)	54.0 (NA)	63.0 (11.6)	62.3 (10.5)	62.0 (10.3)
Sex: Female, Male (Count of Participants)
Female	2 50%	2 28.6%	4 44.4%	4 36.4%	7 46.7%	6 66.7%	4 57.1%	5 83.3%	0 0%	2 8.3%	1 5%	8 15.1%	5 22.7%	0 0%	4 40%	0 0%	0 0%	11 20%	7 14%	72 21.7%
Male	2 50%	5 71.4%	5 55.6%	7 63.6%	8 53.3%	3 33.3%	3 42.9%	1 16.7%	14 100%	22 91.7%	19 95%	45 84.9%	17 77.3%	14 100%	6 60%	1 100%	1 100%	44 80%	43 86%	260 78.3%
Race/Ethnicity, Customized (Number) [Number]
White	4 100%	7 100%	8 88.9%	10 90.9%	13 86.7%	8 88.9%	7 100%	5 83.3%	13 92.9%	22 91.7%	16 80%	51 96.2%	21 95.5%	14 100%	10 100%	1 100%	1 100%	49 89.1%	45 90%	305 91.9%
Black or african american	0 0%	0 0%	1 11.1%	0 0%	0 0%	0 0%	0 0%	1 16.7%	1 7.1%	1 4.2%	1 5%	1 1.9%	0 0%	0 0%	0 0%	0 0%	0 0%	4 7.3%	1 2%	11 3.3%
Asian	0 0%	0 0%	0 0%	1 9.1%	0 0%	1 11.1%	0 0%	0 0%	0 0%	1 4.2%	3 15%	1 1.9%	1 4.5%	0 0%	0 0%	0 0%	0 0%	1 1.8%	3 6%	12 3.6%
Other	0 0%	0 0%	0 0%	0 0%	2 13.3%	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 1.8%	1 2%	4 1.2%
Region of Enrollment (Number) [Number]
Belgium	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	0 0%	10 18.9%	4 18.2%	2 14.3%	2 20%	1 100%	0 0%	3 5.5%	4 8%	27 8.1%
Germany	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 5%	4 7.5%	3 13.6%	2 14.3%	4 40%	0 0%	0 0%	4 7.3%	5 10%	24 7.2%
Great Britain	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 5%	11 20.8%	5 22.7%	1 7.1%	0 0%	0 0%	0 0%	9 16.4%	13 26%	40 12%
Italy	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.2%	1 5%	0 0%	0 0%	0 0%	0 0%	0 0%	1 100%	1 1.8%	0 0%	4 1.2%
Spain	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	7 29.2%	3 15%	12 22.6%	6 27.3%	6 42.9%	2 20%	0 0%	0 0%	17 30.9%	10 20%	63 19%
United States	4 100%	7 100%	9 100%	11 100%	15 100%	9 100%	7 100%	6 100%	14 100%	14 58.3%	14 70%	16 30.2%	4 18.2%	3 21.4%	2 20%	0 0%	0 0%	21 38.2%	18 36%	174 52.4%

Outcome Measures

1. Primary Outcome

Title	Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion
Description	After completion of DLT period (35 days) for the maximum dose cohort. A CRM-based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the "model estimated" MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.
Time Frame	35 days

Outcome Measure Data

Analysis Population Description

All patients who were either assigned or randomized to study.

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
Measure Participants	4	7	9	7	6	14
Number [mg/kg]	2	3	3	2	3	3

2. Primary Outcome

Title	Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion
Description	After completion of DLT period (35 days) for the maximum dose cohort. A CRM-based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the "model estimated" MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.
Time Frame	35 days

Outcome Measure Data

Analysis Population Description

All patients who were either assigned or randomized to study.

Arm/Group Title	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg
Arm/Group Description	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies
Measure Participants	10	11	15
Number [mg]	40	80	80

3. Primary Outcome

Title	Part A: Safety and Tolerability in Terms of Adverse Events
Description	Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
Time Frame	At every treatment and follow up visit until disease progression, an average of 1 year.

Outcome Measure Data

Analysis Population Description

All patients who received at least 1 dose of study treatment.

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
Measure Participants	4	7	9	11	15	9	7	6	14
Number [Patients]	4	7	9	10	15	9	7	5	14

4. Primary Outcome

Title	Part B: ORR (Objective Response Rate) in Patients With IL/2L RM-SCCHN.
Description	proportion of patients who have an objective response at a given visit. ORR will be summarised by treatment group. Objective rate is defined as a CR or PR according to RECIST 1.1.
Time Frame	Assessed at every even-numbered cycles with RECIST until disease progression, up to 12 months.

Outcome Measure Data

Analysis Population Description

All patients with unidimensional measurable disease at baseline as per the RECIST version 1.1 criteria who received at least 1 dose of study treatment barring except for important protocol deviation. Patients who have been manually assigned to treatment in Part B will be excluded from this analysis set. Only treatment groups with non-zero ORR are displayed here.

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	24	20	53	22	55	50
Number (95% Confidence Interval) [percentage of participants]	4.2 105%	10.0 142.9%	22.6 251.1%	4.5 40.9%	21.8 145.3%	26.0 288.9%

5. Secondary Outcome

Title	Part A and B: AZD9150 AUC0-6h at Lead in Day-7
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
Time Frame	Lead in day -7, AUC from time 0 to 6h (post dose).

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B5: AZD9150 in Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	4	7	9	7	6	14	2	53	2	2	0
Geometric Mean (Geometric Coefficient of Variation) [ng.h/ml]	38860 (17.31)	60260 (14.29)	55960 (14.72)	36580 (14.75)	47080 (13.10)	57780 (23.16)	NA (NA)	54290 (17.41)	NA (NA)	NA (NA)

6. Secondary Outcome

Title	Part A and B: AZD9150 Cmax at Lead in Day -7
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
Time Frame	Lead in day -7

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B5: AZD9150 in Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	4	7	9	7	6	14	2	53	2	2	50
Geometric Mean (Geometric Coefficient of Variation) [ng/ml]	21800 (16.76)	30680 (16.31)	27570 (13.21)	18200 (24.82)	23860 (16.10)	27230 (21.54)	NA (NA)	23890 (23.48)	NA (NA)	NA (NA)	25430 (30.23)

7. Secondary Outcome

Title	Part A and B: AZD9150 AUC0-6h at Cycle 2 Day 1
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
Time Frame	Cycle 2 day 1, AUC from time 0 to 6 h post dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B5: AZD9150 in Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	2	7	9	2	6	14	0	53	1	0	0
Geometric Mean (Geometric Coefficient of Variation) [ng.h/ml]	NA (NA)	61810 (22.57)	53480 (23.10)	NA (NA)	44300 (11.64)	51690 (20.72)	62020 (18.43)	NA (NA)

8. Secondary Outcome

Title	Part A and B: AZD9150 Cmax at Cycle 2 Day 1
Time Frame	Cycle 2 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B5: AZD9150 in Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	2	7	9	7	6	14	0	53	1	0	50
Geometric Mean (Geometric Coefficient of Variation) [ng/ml]	NA (NA)	30090 (24.35)	26870 (26.66)	14990 (11.56)	22100 (18.12)	23820 (25.72)	28030 (10.75)	NA (NA)	48540 (26.87)

9. Secondary Outcome

Title	Part A and B: AZD5069 AUC0-12h at Lead in Day -7
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
Time Frame	Lead in day -7, AUC from time 0 to 12h post dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B6b: AZD5069 40mg BID Fasted/Fed
Arm/Group Description	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
Measure Participants	9	11	15	0	1	0	0	0
Geometric Mean (Geometric Coefficient of Variation) [nM.h/L]	7028 (48.04)	17490 (37.71)	17810 (37.46)	NA (NA)

10. Secondary Outcome

Title	Part A and B: AZD5069 Cmax at Lead in Day -7
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
Time Frame	Lead in day -7

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B6b: AZD5069 40mg BID Fasted/Fed
Arm/Group Description	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
Measure Participants	9	11	15	1	2	0	0	0
Geometric Mean (Geometric Coefficient of Variation) [nM/L]	1220 (45.38)	3278 (46.17)	3852 (45.13)	NA (NA)	NA (NA)

11. Secondary Outcome

Title	Part A and B: AZD5069 Cssmax at Cycle 2 Day 1
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at around Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
Time Frame	Cycle 2 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B6b: AZD5069 40mg BID Fasted/Fed
Arm/Group Description	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
Measure Participants	9	11	15	1	22	1	0	0
Geometric Mean (Geometric Coefficient of Variation) [nM/L]	1656 (48.79)	4195 (30.36)	4692 (29.12)	NA (NA)	3336 (23.34)	NA (NA)

12. Secondary Outcome

Title	Part A and B: AZD5069 AUCss at Cycle 2 Day 1
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
Time Frame	Cycle 2 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B6b: AZD5069 40mg BID Fasted/Fed
Arm/Group Description	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival
Measure Participants	9	11	15	1	2	1	0	0
Geometric Mean (Geometric Coefficient of Variation) [nM.h/L]	7903 (56.98)	25500 (21.40)	22020 (37.13)	NA (NA)	NA (NA)	NA (NA)

13. Secondary Outcome

Title	Part A and B: Durvalumab Cmax After Single Dose at Cycle 1 Day 1
Time Frame	Cycle 1 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	0	0	0	0	0	0	0	6	0	0	0	0	0	50
Geometric Mean (Geometric Coefficient of Variation) [ug/ml]	499.3 (32.28)	409.4 (74.66)

14. Secondary Outcome

Title	Part A and B: Durvalumab Ctrough After Multiple Doses at Cycle 4 Day 1
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.
Time Frame	Cycle 4 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	0	0	0	0	0	0	0	6	14	0	0	0	0	55	50
Geometric Mean (Geometric Coefficient of Variation) [ug/ml]	100.6 (52.48)	148.7 (22.38)	107.1 (60.94)	120.6 (31.85)

15. Secondary Outcome

Title	Part A and B: Durvalumab Cmax After Multiple Doses at Cycle 8 Day 1
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
Time Frame	Cycle 8 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	0	0	0	0	1	0	0	0	0	0	2	1	1	55	50
Geometric Mean (Geometric Coefficient of Variation) [ug/ml]	NA (NA)	NA (NA)	NA (NA)	NA (NA)	107.1 (60.94)	120.6 (31.85)

16. Secondary Outcome

Title	Part A and B: Treme Cmax After Single Dose
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
Time Frame	Cycle 1 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme
Arm/Group Description	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
Measure Participants	9	7	6
Geometric Mean (Geometric Coefficient of Variation) [ng/ml]	23840 (23.39)	20260 (17.71)	21290 (20.67)

17. Secondary Outcome

Title	Part A and B: Treme Ctrough After Multiple Doses at Cycle 4 Day 1
Description	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.
Time Frame	Cycle 4 day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic population. PK parameters were estimated from PK evaluable subjects

Arm/Group Title	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme
Arm/Group Description	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD
Measure Participants	2	1	6
Geometric Mean (Geometric Coefficient of Variation) [ng/ml]	NA (NA)	NA (NA)	2999 (9.780)

18. Secondary Outcome

Title	Part A and B: Immunogenecity as Percent of ADA Positive Subjects
Description	Subject was considered ADA positive if any post dose samples had ADA positive result. Result was not stratified based on post dose time points.
Time Frame	Throughout the study, up to 3.3 years

Outcome Measure Data

Analysis Population Description

immunogenicity population, patient who provided at least one ADA samples for analysis. Arms were combined together to help in data interpretation since there were not many ADA positive subjects in each to draw any useful conclusion.

Arm/Group Title	Part A and B AZD9150 ADA	Part A and B Durva ADA
Arm/Group Description	All subjects who received AZD9150 and provided ADA samples	All subjects who received durva and provided ADA samples.
Measure Participants	247	440
Number [% of total analyzed patient]	2.8	5

19. Secondary Outcome

Title	Part A: Antitumour Activity in Monotherapy and Combination Arms of Study
Description	complete response, partial response, stable disease or progressive disease based on RECIST
Time Frame	assessed at every even numbered cycle with RECIST until disease progression, an average of 1 year

Outcome Measure Data

Analysis Population Description

All patients who received at least 1 dose of study treatment

Arm/Group Title	Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg	Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg	Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg	Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg	Part A4 Cohort 1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme	Part A4 Cohort 3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme	Part A6: AZD9150/MEDI4736
Arm/Group Description	Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.
Measure Participants	4	7	9	11	15	9	7	6	14
Complete response	0	0	0	1	0	0	0	0	0
Partial response	1	1	0	0	0	1	0	1	1
Stable disease	1	3	1	5	3	2	2	2	4
Progression	2	3	6	4	9	6	5	1	9

20. Secondary Outcome

Title	Part B: Safety and Tolerability in Terms of Adverse Events
Description	Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
Time Frame	At every treatment and follow up visit until disease progression, an average of 1 year.

Outcome Measure Data

Analysis Population Description

All patients who received at least 1 dose of study treatment.

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B5: AZD9150 in Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B6b: AZD5069 40mg BID Fasted/Fed	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	24	20	53	22	14	10	1	1	55	50
Number [Patients]	22	19	51	20	14	10	1	1	55	48

21. Secondary Outcome

Title	Part B: Secondary Measures Change in Efficacy - Disease Control Rate
Description	Disease control rate is confirmed complete response (CR), confirmed partial response (PR) and stable disease (SD)
Time Frame	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months

Outcome Measure Data

Analysis Population Description

All patients with unidimensional measurable disease at baseline as per the RECIST version 1.1 criteria who received at least 1 dose of study treatment barring except for important protocol deviation. Patients who have been manually assigned to treatment in Part B will be excluded from this analysis set. Only treatment groups with non-zero DCR are presented here.

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B5: AZD9150 in Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	24	20	53	22	14	55	50
Number (80% Confidence Interval) [Percentage of participants]	20.8 520%	20.0 285.7%	37.7 418.9%	18.2 165.5%	28.6 190.7%	32.7 363.3%	44.0 628.6%

22. Secondary Outcome

Title	Part B: Secondary Measures Change in Efficacy - Duration of Overall Response
Description	Duration of overall response is according to RECIST 1.1 criteria measured from the time measurement criteria are first met for CR or PR, whichever is first recorded, until the first date that recurrent or PD is objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR is only applied to treatment groups where at least one response patient was recorded.
Time Frame	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 48 months

Outcome Measure Data

Analysis Population Description

All patients with unidimensional measurable disease at baseline as per the RECIST version 1.1 criteria who received at least 1 dose of study treatment barring except for important protocol deviation. Patients who have been manually assigned to treatment in Part B will be excluded from this analysis set. Only treatment groups with non-zero DoR are presented here.

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	24	20	53	22	55	50
Median (Full Range) [Weeks]	165.9	29.0	66.0	37.0	48.6	27.57

23. Secondary Outcome

Title	Part B: Secondary Measures Change in Efficacy - PFS
Description	progression-free survival (PFS): defined as the time from randomisation to the first documentation of PD as determined by the Investigator or death from any cause, whichever occurs first. Only includes progression events that occur within 126 days of the last evaluable assessment
Time Frame	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months

Outcome Measure Data

Analysis Population Description

All patients with unidimensional measurable disease at baseline as per the RECIST version 1.1 criteria who received at least 1 dose of study treatment barring except for important protocol deviation. Patients who have been manually assigned to treatment in Part B will be excluded from this analysis set.

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B5: AZD9150 in Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B6b: AZD5069 40mg BID Fasted/Fed	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	24	20	53	22	14	10	1	1	55	50
Median (80% Confidence Interval) [Days]	51.0	51.0	66.5	52.00	47.0	41.5	47.0	51.0	85.0	104.0

24. Secondary Outcome

Title	Part B: Secondary Measures Change in Efficacy - OS
Description	overall survival (OS) - defined as the time from treatment allocation to death from any cause
Time Frame	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 15 months

Outcome Measure Data

Analysis Population Description

All patients with unidimensional measurable disease at baseline as per the RECIST version 1.1 criteria who received at least 1 dose of study treatment barring except for important protocol deviation. Patients who have been manually assigned to treatment in Part B will be excluded from this analysis set.

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B5: AZD9150 in Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B6b: AZD5069 40mg BID Fasted/Fed	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	24	20	53	22	14	10	1	1	55	50
Median (80% Confidence Interval) [Days]	203.0	288.0	199.0	254.0	175.0	451.0	436.0	318.0	330.0	353.0

25. Secondary Outcome

Title	Part B: Secondary Measures Change in Efficacy - OS at 12 Months
Description	proportion of patients alive at 12 months: the percentage of patients surviving at 12 months after randomization to study drug
Time Frame	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months

Outcome Measure Data

Analysis Population Description

All patients with unidimensional measurable disease at baseline as per the RECIST version 1.1 criteria who received at least 1 dose of study treatment barring except for important protocol deviation. Patients who have been manually assigned to treatment in Part B will be excluded from this analysis set. Only treatment groups with non-zero OS at 12 months are presented here.

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B5: AZD9150 in Naiive Patients	Part B6:AZD5069 in Naiive Patients	Part B6a: AZD5069 40mg BID Fed/Fasted	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	24	20	53	22	14	10	1	55	50
Number (80% Confidence Interval) [Percentage of participants]	18.2 455%	42.5 607.1%	39.7 441.1%	46.4 421.8%	30.8 205.3%	60.0 666.7%	100.0 1428.6%	46.5 775%	46.3 330.7%

26. Secondary Outcome

Title	Part B: Evaluation of AZD9150 Pharmacodynamics: Change in STAT3 RNA Level From Baseline
Description	Percent STAT3 RNA change in expression level in peripheral blood in patients who had baseline (Screening or Day -7) sample for comparison. Data were only available for B1, B3, B5, B7 and B8.
Time Frame	At Cycle 2 Day 1 vs. Baseline

Outcome Measure Data

Analysis Population Description

Pharmacodynamics Set

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B5: AZD9150 in Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	8	29	5	30	34
Median (Full Range) [Percent]	-2.9	-9.8	-6.7	-22.9	-27.1

27. Secondary Outcome

Title	Part B: Evaluation of PDL1 Expression
Description	Tumors with PDL1-positive tumor cells at the designated cutoff. Data were only available for B1, B2, B3, B4, B7 and B8.
Time Frame	in baseline tumor samples

Outcome Measure Data

Analysis Population Description

Patients with evaluable tumor samples

Arm/Group Title	Part B1:AZD9150+MEDI4736:PDL1 Pretreated	Part B2:AZD5069+MEDI4736:PDL1 Pretreated	Part B3: AZD9150+MED4736:Naiive 2L	Part B4:AZD5069+MEDI4736:Naiive Patients	Part B7: AZD9150+MEDI4736: Naiive 1L	Part B8: AZD9150 (Every Other Week)+MEDI4736: Naive 1L
Arm/Group Description	Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival
Measure Participants	21	18	49	21	48	36
Participants with PDL1 expression >=1% in tumor cells	15 375%	12 171.4%	27 300%	15 136.4%	27 180%	21 233.3%
Participants with PDL1 expression >=50% in tumor cells	8 200%	4 57.1%	12 133.3%	5 45.5%	8 53.3%	7 77.8%

Adverse Events

Time Frame	For monotherapy arms (AZD9150 or AZD5069 with no MEDl4736), TEAEs from the first dose date of the study drug up to 30 days after the last dose date. Similarly, treatment-emergent SAEs from the first dose date of the study drug up to 35 days after the last dose date. For combination therapy arms (AZD9150 or AZD5069 with MEDl4736), use both TEAEs and treatment-emergent SAEs from the first dose date of the study drug up to 90 days after the last dose date of MEDl4736, an average of 1 year.
Arm/Group Title	A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg		A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg		A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg		A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg		A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg		A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme		A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp		B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp		B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive		B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive		B5: AZD9150 3mg/kg		B6: AZD5069 40mg BID		B6a: AZD5069 40mg BID Fed/Fasted		B6b: AZD5069 40mg BID Fasted/Fed		B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
Arm/Group Description	Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)		Description (Arm-group)
All Cause Mortality
	A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg		A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg		A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg		A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg		A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg		A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme		A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp		B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp		B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive		B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive		B5: AZD9150 3mg/kg		B6: AZD5069 40mg BID		B6a: AZD5069 40mg BID Fed/Fasted		B6b: AZD5069 40mg BID Fasted/Fed		B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
	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	2/4 (50%)		3/7 (42.9%)		5/9 (55.6%)		6/11 (54.5%)		9/15 (60%)		8/9 (88.9%)		6/7 (85.7%)		1/6 (16.7%)		7/14 (50%)		21/24 (87.5%)		18/20 (90%)		41/53 (77.4%)		16/22 (72.7%)		11/14 (78.6%)		9/10 (90%)		1/1 (100%)		1/1 (100%)		35/55 (63.6%)		22/50 (44%)
Serious Adverse Events
	A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg		A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg		A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg		A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg		A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg		A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme		A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp		B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp		B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive		B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive		B5: AZD9150 3mg/kg		B6: AZD5069 40mg BID		B6a: AZD5069 40mg BID Fed/Fasted		B6b: AZD5069 40mg BID Fasted/Fed		B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
	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	0/4 (0%)		1/7 (14.3%)		3/9 (33.3%)		5/11 (45.5%)		5/15 (33.3%)		5/9 (55.6%)		2/7 (28.6%)		2/6 (33.3%)		3/14 (21.4%)		10/24 (41.7%)		7/20 (35%)		30/53 (56.6%)		9/22 (40.9%)		9/14 (64.3%)		6/10 (60%)		1/1 (100%)		0/1 (0%)		28/55 (50.9%)		21/50 (42%)
Blood and lymphatic system disorders
Anaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Blood loss anaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Thrombocytopenia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	2
Cardiac disorders
Atrial fibrillation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	1/9 (11.1%)	2	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Atrial flutter	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cardiac failure	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cardiotoxicity	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Myocarditis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Palpitations	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pericardial effusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pulmonary valve incompetence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Tachycardia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Endocrine disorders
Hypercalcaemia of malignancy	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hyperthyroidism	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypothyroidism	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eye disorders
Vision blurred	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	2/15 (13.3%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Abdominal pain lower	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Abdominal pain upper	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Autoimmune enteropathy	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Colitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Colitis ulcerative	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Diarrhoea	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Dysphagia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Enterocolitis haemorrhagic	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gastrointestinal haemorrhage	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Haematemesis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Intestinal haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Intestinal obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Lower gastrointestinal haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Melaena	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Mouth haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Nausea	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Obstruction gastric	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oesophageal perforation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oesophagitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Upper gastrointestinal haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Vomiting	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
General disorders
Asthenia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	4/53 (7.5%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Chest pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Complication associated with device	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	2	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Euthanasia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Face oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Fatigue	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Localised oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Medical device site haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Mucosal dryness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Mucosal inflammation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Multiple organ dysfunction syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Pyrexia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Hepatobiliary disorders
Cholestasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Drug-induced liver injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Hepatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Hyperbilirubinaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Immune-mediated hepatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	2
Jaundice cholestatic	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Immune system disorders
Anaphylactic reaction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infections and infestations
Bacteraemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Bronchitis bacterial	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Campylobacter gastroenteritis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cellulitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	2/9 (22.2%)	2	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Device related infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Diverticulitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Endocarditis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Infestation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Lower respiratory tract infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Lung infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lymphangitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Mucosal infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Neutropenic sepsis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pleural infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pneumonia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	1/15 (6.7%)	1	1/9 (11.1%)	1	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	3/24 (12.5%)	3	2/20 (10%)	2	2/53 (3.8%)	2	2/22 (9.1%)	2	1/14 (7.1%)	1	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Pneumonia pneumococcal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Respiratory tract infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	2/14 (14.3%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Sepsis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Staphylococcal bacteraemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Stoma site infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Superinfection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Upper respiratory tract infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Injury, poisoning and procedural complications
Hip fracture	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infusion related reaction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Procedural pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Stoma site haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Tracheal obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Investigations
Alanine aminotransferase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Amylase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Aspartate aminotransferase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	1/20 (5%)	1	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	1/50 (2%)	1
Blood bilirubin increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood creatine phosphokinase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Blood creatinine increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gamma-glutamyltransferase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oxygen saturation decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Transaminases increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Weight decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypercalcaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hyperglycaemic hyperosmolar nonketotic syndrome	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hyponatraemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Malnutrition	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Back pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Muscle haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pain in jaw	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Tumour flare	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tumour haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	2/14 (14.3%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	6
Tumour invasion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Nervous system disorders
Cerebral haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cerebral venous thrombosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Facial nerve disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Hypoxic-ischaemic encephalopathy	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ischaemic stroke	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Presyncope	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Product Issues
Device dislocation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Device extrusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Psychiatric disorders
Confusional state	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Delirium	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Mental status changes	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Renal and urinary disorders
Acute kidney injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Calculus bladder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Renal failure	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Urinary tract obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Asphyxia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Aspiration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Chronic obstructive pulmonary disease	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	2	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Dyspnoea	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	4/53 (7.5%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Dyspnoea exertional	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Haemoptysis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypoxia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Laryngeal oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oropharyngeal pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pleural effusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	5	0/22 (0%)	0	1/14 (7.1%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	1/50 (2%)	1
Pneumonia aspiration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	3/53 (5.7%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	2/50 (4%)	2
Pneumonitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Pneumothorax	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pulmonary alveolar haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Pulmonary embolism	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Respiratory failure	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	1/50 (2%)	1
Skin and subcutaneous tissue disorders
Skin haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Vascular disorders
Arterial haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Deep vein thrombosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Embolism	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Hypotension	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Peripheral artery occlusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Superior vena cava occlusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Other (Not Including Serious) Adverse Events
	A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg		A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg		A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg		A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg		A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg		A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme		A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme		A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp		B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp		B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive		B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive		B5: AZD9150 3mg/kg		B6: AZD5069 40mg BID		B6a: AZD5069 40mg BID Fed/Fasted		B6b: AZD5069 40mg BID Fasted/Fed		B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg		B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
	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%)		7/7 (100%)		9/9 (100%)		10/11 (90.9%)		15/15 (100%)		9/9 (100%)		7/7 (100%)		5/6 (83.3%)		14/14 (100%)		22/24 (91.7%)		19/20 (95%)		51/53 (96.2%)		20/22 (90.9%)		14/14 (100%)		10/10 (100%)		1/1 (100%)		1/1 (100%)		55/55 (100%)		48/50 (96%)
Blood and lymphatic system disorders
Anaemia	2/4 (50%)	3	3/7 (42.9%)	8	1/9 (11.1%)	1	2/11 (18.2%)	2	3/15 (20%)	3	4/9 (44.4%)	5	0/7 (0%)	0	2/6 (33.3%)	6	4/14 (28.6%)	6	5/24 (20.8%)	7	8/20 (40%)	8	20/53 (37.7%)	39	6/22 (27.3%)	11	3/14 (21.4%)	6	7/10 (70%)	7	0/1 (0%)	0	0/1 (0%)	0	20/55 (36.4%)	46	23/50 (46%)	30
Anaemia macrocytic	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Bone marrow failure	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Disseminated intravascular coagulation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Febrile neutropenia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Haemolysis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypofibrinogenaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Increased tendency to bruise	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Iron deficiency anaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	3/15 (20%)	3	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Leukocytosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	1/55 (1.8%)	1	0/50 (0%)	0
Leukopenia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	1/22 (4.5%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	0/50 (0%)	0
Lymph node pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lymphadenitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lymphadenopathy	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lymphatic disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lymphopenia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	2
Neutropenia	2/4 (50%)	3	0/7 (0%)	0	3/9 (33.3%)	5	2/11 (18.2%)	4	3/15 (20%)	6	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	4/20 (20%)	8	2/53 (3.8%)	10	3/22 (13.6%)	23	0/14 (0%)	0	3/10 (30%)	7	0/1 (0%)	0	0/1 (0%)	0	5/55 (9.1%)	17	5/50 (10%)	7
Neutrophilia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pancytopenia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Thrombocytopenia	2/4 (50%)	3	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	2/9 (22.2%)	4	2/7 (28.6%)	2	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	8/53 (15.1%)	13	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	10/55 (18.2%)	12	10/50 (20%)	11
Thrombocytopenic purpura	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cardiac disorders
Aortic valve incompetence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Atrial fibrillation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Atrioventricular block first degree	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Bradycardia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Bundle branch block right	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cardiac arrest	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cardiogenic shock	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Defect conduction intraventricular	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Palpitations	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	2	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pericardial effusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pericarditis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Sinus bradycardia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Sinus tachycardia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	3
Tachyarrhythmia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/55 (0%)	0	0/50 (0%)	0
Tachycardia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Tricuspid valve incompetence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Congenital, familial and genetic disorders
Macroglossia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Ear and labyrinth disorders
Deafness unilateral	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ear congestion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Ear discomfort	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ear pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	3/24 (12.5%)	5	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	4	1/50 (2%)	1
Ear swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypoacusis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Middle ear effusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tinnitus	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Vertigo	1/4 (25%)	1	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Endocrine disorders
Cushingoid	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Hyperthyroidism	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	2/53 (3.8%)	2	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Hypothyroidism	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	3/15 (20%)	3	1/9 (11.1%)	1	2/7 (28.6%)	2	1/6 (16.7%)	1	1/14 (7.1%)	1	1/24 (4.2%)	1	1/20 (5%)	1	5/53 (9.4%)	5	3/22 (13.6%)	3	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	7	3/50 (6%)	3
Inappropriate antidiuretic hormone secretion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Eye disorders
Amblyopia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blepharitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Cataract	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Conjunctival haemorrhage	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Corneal epithelium defect	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Diplopia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dry eye	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Exophthalmos	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eye inflammation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eye irritation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eye pain	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eye pruritus	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eye swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eyelid ptosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Keratitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lacrimation increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Limbal swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ocular hyperaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Ophthalmoplegia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Optic nerve disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Periorbital oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Photophobia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Pupils unequal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Retinopathy	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Swelling of eyelid	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Vision blurred	1/4 (25%)	1	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Visual impairment	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	2	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	3	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Abdominal distension	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	1/53 (1.9%)	1	3/22 (13.6%)	3	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Abdominal pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	2	2/9 (22.2%)	3	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	1/20 (5%)	1	4/53 (7.5%)	4	1/22 (4.5%)	1	2/14 (14.3%)	2	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	4	7/50 (14%)	7
Abdominal pain lower	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	2/11 (18.2%)	2	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Abdominal pain upper	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	4	0/50 (0%)	0
Abdominal rigidity	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Abdominal tenderness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Abnormal faeces	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Anal incontinence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Angular cheilitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Aphthous ulcer	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	2	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Ascites	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	2	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Breath odour	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Cheilitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Colitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Constipation	0/4 (0%)	0	2/7 (28.6%)	2	1/9 (11.1%)	1	1/11 (9.1%)	2	1/15 (6.7%)	1	1/9 (11.1%)	1	2/7 (28.6%)	2	0/6 (0%)	0	0/14 (0%)	0	5/24 (20.8%)	5	4/20 (20%)	5	14/53 (26.4%)	17	3/22 (13.6%)	4	2/14 (14.3%)	2	2/10 (20%)	2	1/1 (100%)	1	0/1 (0%)	0	11/55 (20%)	15	11/50 (22%)	11
Defaecation urgency	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dental caries	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Diarrhoea	1/4 (25%)	3	2/7 (28.6%)	2	2/9 (22.2%)	2	0/11 (0%)	0	4/15 (26.7%)	12	3/9 (33.3%)	4	1/7 (14.3%)	1	3/6 (50%)	5	5/14 (35.7%)	5	6/24 (25%)	9	2/20 (10%)	3	11/53 (20.8%)	13	5/22 (22.7%)	11	1/14 (7.1%)	1	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	9/55 (16.4%)	12	12/50 (24%)	18
Dry mouth	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	2/14 (14.3%)	2	1/24 (4.2%)	1	1/20 (5%)	1	4/53 (7.5%)	4	0/22 (0%)	0	2/14 (14.3%)	2	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	2/50 (4%)	2
Dumping syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Duodenal ulcer	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Duodenitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Dyspepsia	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	0/20 (0%)	0	3/53 (5.7%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Dysphagia	0/4 (0%)	0	1/7 (14.3%)	2	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	1/9 (11.1%)	2	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	0/20 (0%)	0	6/53 (11.3%)	7	4/22 (18.2%)	5	2/14 (14.3%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	6/55 (10.9%)	6	8/50 (16%)	8
Enterocolitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Epigastric discomfort	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Eructation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Faeces discoloured	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Flatulence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Frequent bowel movements	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Functional gastrointestinal disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gastrointestinal disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Gastrointestinal haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Gastrointestinal polyp	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gastrooesophageal reflux disease	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	2/15 (13.3%)	2	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	0/50 (0%)	0
Gingival bleeding	0/4 (0%)	0	1/7 (14.3%)	2	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Gingival pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Glossitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Glossodynia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Haematemesis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Haematochezia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	2/9 (22.2%)	3	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Haemorrhoids	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypoaesthesia oral	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ileus	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Large intestinal obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Large intestine polyp	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lip dry	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Lip pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Lip swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Loose tooth	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Melaena	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Mouth haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	2/53 (3.8%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Mouth ulceration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Nausea	0/4 (0%)	0	2/7 (28.6%)	4	2/9 (22.2%)	2	3/11 (27.3%)	3	4/15 (26.7%)	7	4/9 (44.4%)	4	1/7 (14.3%)	1	3/6 (50%)	5	0/14 (0%)	0	4/24 (16.7%)	5	2/20 (10%)	2	9/53 (17%)	9	5/22 (22.7%)	5	1/14 (7.1%)	1	3/10 (30%)	4	1/1 (100%)	1	0/1 (0%)	0	11/55 (20%)	12	8/50 (16%)	13
Noninfective gingivitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Odynophagia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	3/53 (5.7%)	3	1/22 (4.5%)	1	1/14 (7.1%)	2	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	4	0/50 (0%)	0
Oesophageal pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oesophagitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oral discharge	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Oral disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oral dysaesthesia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Oral mucosal blistering	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Oral pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	5/50 (10%)	6
Palatal disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Paraesthesia oral	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Rectal haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Reflux gastritis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Salivary gland pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Salivary hypersecretion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Stomatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	2/11 (18.2%)	2	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	4/53 (7.5%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	1/55 (1.8%)	1	1/50 (2%)	1
Tongue haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Tongue ulceration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Toothache	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	2/15 (13.3%)	2	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Vomiting	1/4 (25%)	1	1/7 (14.3%)	1	1/9 (11.1%)	1	2/11 (18.2%)	2	5/15 (33.3%)	7	3/9 (33.3%)	4	0/7 (0%)	0	2/6 (33.3%)	2	0/14 (0%)	0	1/24 (4.2%)	1	3/20 (15%)	3	9/53 (17%)	10	3/22 (13.6%)	4	3/14 (21.4%)	4	2/10 (20%)	2	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	7	6/50 (12%)	8
General disorders
Application site erythema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Application site wound	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Asthenia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	5/24 (20.8%)	6	2/20 (10%)	5	11/53 (20.8%)	18	5/22 (22.7%)	7	4/14 (28.6%)	4	2/10 (20%)	2	0/1 (0%)	0	0/1 (0%)	0	9/55 (16.4%)	24	5/50 (10%)	7
Catheter site discharge	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Catheter site erythema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	2	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Catheter site pain	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Chest discomfort	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Chest pain	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	2/15 (13.3%)	5	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	1	4/53 (7.5%)	6	2/22 (9.1%)	2	1/14 (7.1%)	1	1/10 (10%)	1	1/1 (100%)	1	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Chills	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	2/9 (22.2%)	2	2/7 (28.6%)	2	1/6 (16.7%)	1	2/14 (14.3%)	2	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	2/50 (4%)	2
Complication associated with device	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	2
Early satiety	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Face oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	1	4/53 (7.5%)	4	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Facial pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	3/50 (6%)	4
Fatigue	0/4 (0%)	0	4/7 (57.1%)	5	5/9 (55.6%)	5	3/11 (27.3%)	6	4/15 (26.7%)	4	4/9 (44.4%)	5	4/7 (57.1%)	6	2/6 (33.3%)	4	7/14 (50%)	7	7/24 (29.2%)	9	7/20 (35%)	7	20/53 (37.7%)	25	6/22 (27.3%)	7	2/14 (14.3%)	2	4/10 (40%)	4	0/1 (0%)	0	1/1 (100%)	1	24/55 (43.6%)	29	17/50 (34%)	21
Feeling abnormal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Feeling hot	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Feeling jittery	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Fibrosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gait disturbance	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
General physical health deterioration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	2/10 (20%)	2	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Generalised oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Impaired healing	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Inflammation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/55 (0%)	0	0/50 (0%)	0
Influenza like illness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	3	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Infusion site erythema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Localised oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	2
Malaise	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	2/15 (13.3%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	4	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Medical device pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Mucosal inflammation	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	1/11 (9.1%)	2	2/15 (13.3%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	1/14 (7.1%)	1	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	2/50 (4%)	2
Mucosal ulceration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Necrosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Non-cardiac chest pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	1/20 (5%)	1	3/53 (5.7%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Oedema peripheral	0/4 (0%)	0	2/7 (28.6%)	2	1/9 (11.1%)	3	2/11 (18.2%)	2	1/15 (6.7%)	1	2/9 (22.2%)	2	1/7 (14.3%)	1	2/6 (33.3%)	3	3/14 (21.4%)	3	2/24 (8.3%)	2	1/20 (5%)	1	4/53 (7.5%)	6	2/22 (9.1%)	2	0/14 (0%)	0	2/10 (20%)	3	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	10	0/50 (0%)	0
Pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	2/11 (18.2%)	2	0/15 (0%)	0	3/9 (33.3%)	3	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	3/24 (12.5%)	3	0/20 (0%)	0	4/53 (7.5%)	5	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Performance status decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Peripheral swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	2/14 (14.3%)	3	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Pyrexia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	3/11 (27.3%)	3	2/15 (13.3%)	2	2/9 (22.2%)	2	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	4/24 (16.7%)	7	6/20 (30%)	10	7/53 (13.2%)	10	2/22 (9.1%)	3	3/14 (21.4%)	4	2/10 (20%)	2	1/1 (100%)	1	1/1 (100%)	2	8/55 (14.5%)	10	3/50 (6%)	3
Secretion discharge	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	1/14 (7.1%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Ulcer	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Xerosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Hepatobiliary disorders
Hepatic haematoma	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Hepatic pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hepatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	3
Hepatotoxicity	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	2/14 (14.3%)	5	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hyperbilirubinaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Immune-mediated hepatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	2
Immune system disorders
Hypersensitivity	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Seasonal allergy	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	2/11 (18.2%)	2	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infections and infestations
Abscess limb	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Abscess neck	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Arthritis bacterial	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Asymptomatic bacteriuria	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Atypical pneumonia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Bacteraemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Bacterial vaginosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Bronchitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	2/15 (13.3%)	2	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Candida infection	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	1/9 (11.1%)	2	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	2
Cat scratch disease	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cellulitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	4	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Clostridium difficile infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Conjunctivitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Cystitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	0/50 (0%)	0
Cytomegalovirus infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dental fistula	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Device related infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Diverticulitis	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ear infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	3	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Escherichia infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Folliculitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Fungal infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/55 (0%)	0	0/50 (0%)	0
Gastric infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gastroenteritis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Gastrointestinal candidiasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gastrointestinal infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gingivitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Herpes simplex	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Herpes virus infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Herpes zoster	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Implant site cellulitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infected fistula	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infected seroma	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Influenza	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Localised infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lower respiratory tract infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	1/50 (2%)	1
Lung infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Mastitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Medical device site infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Mucosal infection	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Nail infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Nasopharyngitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	3/53 (5.7%)	8	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	5	1/50 (2%)	1
Oral candidiasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	1/20 (5%)	1	1/53 (1.9%)	1	2/22 (9.1%)	3	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/55 (9.1%)	5	1/50 (2%)	1
Oral fungal infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oral herpes	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Oropharyngeal candidiasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Otitis externa	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Paronychia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Peritonitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pneumonia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	2/15 (13.3%)	2	2/9 (22.2%)	2	1/7 (14.3%)	1	1/6 (16.7%)	2	0/14 (0%)	0	2/24 (8.3%)	2	1/20 (5%)	1	2/53 (3.8%)	3	1/22 (4.5%)	1	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	5	1/50 (2%)	1
Pneumonia pneumococcal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Post procedural infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pyuria	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Respiratory tract infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	3/14 (21.4%)	3	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	5	1/50 (2%)	1
Rhinitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Sepsis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Sinusitis	1/4 (25%)	1	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	2/15 (13.3%)	3	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	6	0/50 (0%)	0
Skin candida	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin infection	0/4 (0%)	0	0/7 (0%)	0	2/9 (22.2%)	2	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Soft tissue infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	3
Sputum purulent	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Staphylococcal infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Superinfection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tinea infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tooth abscess	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tooth infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	0/50 (0%)	0
Trichomoniasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Upper respiratory tract infection	0/4 (0%)	0	1/7 (14.3%)	1	1/9 (11.1%)	1	1/11 (9.1%)	1	1/15 (6.7%)	2	1/9 (11.1%)	2	2/7 (28.6%)	2	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	7	0/20 (0%)	0	2/53 (3.8%)	3	1/22 (4.5%)	3	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	4	0/50 (0%)	0
Urinary tract infection	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	4/15 (26.7%)	9	1/9 (11.1%)	3	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	4/53 (7.5%)	5	0/22 (0%)	0	0/14 (0%)	0	3/10 (30%)	6	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	11	0/50 (0%)	0
Viral upper respiratory tract infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Vulvovaginal mycotic infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Wound infection	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Injury, poisoning and procedural complications
Animal scratch	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Bone fissure	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Contusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	3/9 (33.3%)	3	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Craniocerebral injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Face injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Fall	2/4 (50%)	3	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	2	2/9 (22.2%)	2	0/7 (0%)	0	1/6 (16.7%)	2	1/14 (7.1%)	2	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	4	0/50 (0%)	0
Gastrointestinal stoma complication	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gastrostomy tube site complication	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hand fracture	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Head injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Incision site complication	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Inflammation of wound	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infusion related reaction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	3
Joint injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Limb injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Muscle strain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Osteoradionecrosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Periorbital haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Post procedural complication	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Post procedural haematoma	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Post procedural haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Post procedural oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Postoperative wound complication	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Procedural haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Procedural pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	3/53 (5.7%)	4	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Radiation injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Radiation skin injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Rib fracture	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Seroma	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin abrasion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	2/9 (22.2%)	2	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	2	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin laceration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	2	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin wound	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Stoma site discharge	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Stoma site haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Stoma site oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Stoma site pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tibia fracture	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tracheal haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Tracheal obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tracheostomy malfunction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	3	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Wound haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Wound secretion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Investigations
Activated partial thromboplastin time prolonged	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Alanine aminotransferase	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Alanine aminotransferase abnormal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Alanine aminotransferase increased	2/4 (50%)	2	4/7 (57.1%)	6	0/9 (0%)	0	1/11 (9.1%)	1	2/15 (13.3%)	2	4/9 (44.4%)	8	1/7 (14.3%)	1	3/6 (50%)	4	9/14 (64.3%)	11	8/24 (33.3%)	12	1/20 (5%)	2	13/53 (24.5%)	24	1/22 (4.5%)	1	3/14 (21.4%)	4	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	24/55 (43.6%)	34	20/50 (40%)	32
Aspartate aminotransferase	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Aspartate aminotransferase increased	2/4 (50%)	2	3/7 (42.9%)	4	1/9 (11.1%)	1	1/11 (9.1%)	1	2/15 (13.3%)	2	5/9 (55.6%)	8	2/7 (28.6%)	2	3/6 (50%)	4	9/14 (64.3%)	12	7/24 (29.2%)	11	2/20 (10%)	3	13/53 (24.5%)	25	1/22 (4.5%)	1	3/14 (21.4%)	3	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	21/55 (38.2%)	29	21/50 (42%)	37
Aspiration pleural cavity	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	2
Bilirubin conjugated increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Biopsy site unspecified abnormal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood alkaline phosphatase	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood alkaline phosphatase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	2	1/15 (6.7%)	1	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	1/20 (5%)	2	3/53 (5.7%)	5	1/22 (4.5%)	2	4/14 (28.6%)	4	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	4/50 (8%)	5
Blood bicarbonate increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood bilirubin increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	2/15 (13.3%)	2	3/9 (33.3%)	3	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	4	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	2/50 (4%)	3
Blood calcium decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood calcium increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Blood cholesterol decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood cholesterol increased	1/4 (25%)	1	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood creatine increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood creatine phosphokinase	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood creatine phosphokinase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	1/20 (5%)	1	2/53 (3.8%)	3	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	7	5/50 (10%)	8
Blood creatinine increased	1/4 (25%)	1	2/7 (28.6%)	2	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	2	3/53 (5.7%)	3	2/22 (9.1%)	2	1/14 (7.1%)	1	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	7	4/50 (8%)	6
Blood fibrinogen decreased	1/4 (25%)	1	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	2	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood fibrinogen increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood folate decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood glucose increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	2	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood lactate dehydrogenase decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood lactate dehydrogenase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	1/50 (2%)	1
Blood phosphorus decreased	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood phosphorus increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood potassium decreased	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood potassium increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood pressure increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Blood pressure orthostatic	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood thyroid stimulating hormone increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	3/50 (6%)	3
Blood triglycerides increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	2
Blood urea increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Blood uric acid increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
C-reactive protein increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	2/55 (3.6%)	3	0/50 (0%)	0
Computerised tomogram thorax abnormal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Electrocardiogram qt prolonged	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	1	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gamma-glutamyltransferase	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Gamma-glutamyltransferase increased	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	2/20 (10%)	3	6/53 (11.3%)	7	1/22 (4.5%)	1	1/14 (7.1%)	1	2/10 (20%)	3	0/1 (0%)	0	0/1 (0%)	0	11/55 (20%)	12	6/50 (12%)	7
Glucose urine present	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Grip strength decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Haptoglobin decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	2/50 (4%)	2
Haptoglobin increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Heart rate irregular	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hepatic enzyme increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	3
High density lipoprotein decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
International normalised ratio increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lipase increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Liver function test abnormal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Liver function test increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Lymphocyte count decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	1/50 (2%)	1
Neutrophil count decreased	1/4 (25%)	4	2/7 (28.6%)	6	1/9 (11.1%)	1	2/11 (18.2%)	27	4/15 (26.7%)	7	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	4/14 (28.6%)	5	0/24 (0%)	0	0/20 (0%)	0	4/53 (7.5%)	10	3/22 (13.6%)	4	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	28	6/50 (12%)	7
Neutrophil count increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Oxygen saturation decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Platelet count decreased	1/4 (25%)	3	3/7 (42.9%)	7	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	2/9 (22.2%)	3	0/7 (0%)	0	1/6 (16.7%)	1	6/14 (42.9%)	8	3/24 (12.5%)	7	0/20 (0%)	0	8/53 (15.1%)	29	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	10/55 (18.2%)	30	8/50 (16%)	10
Protein c increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/55 (0%)	0	0/50 (0%)	0
Prothrombin time prolonged	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Quality of life decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Sinus rhythm	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Sputum abnormal	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Thyroxine free decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Transaminases	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Transaminases increased	0/4 (0%)	0	1/7 (14.3%)	1	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	3/24 (12.5%)	3	0/20 (0%)	0	3/53 (5.7%)	5	1/22 (4.5%)	1	2/14 (14.3%)	4	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	3
Tri-iodothyronine decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Urine output decreased	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Vitamin b12 decreased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Weight decreased	1/4 (25%)	1	2/7 (28.6%)	2	1/9 (11.1%)	2	0/11 (0%)	0	0/15 (0%)	0	2/9 (22.2%)	3	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	3/24 (12.5%)	3	2/20 (10%)	2	11/53 (20.8%)	12	3/22 (13.6%)	3	2/14 (14.3%)	2	1/10 (10%)	1	1/1 (100%)	1	0/1 (0%)	0	6/55 (10.9%)	6	5/50 (10%)	5
Weight increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	7	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
White blood cell count decreased	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	1/15 (6.7%)	2	0/9 (0%)	0	1/7 (14.3%)	2	1/6 (16.7%)	1	3/14 (21.4%)	3	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	8/55 (14.5%)	15	3/50 (6%)	3
White blood cell count increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Metabolism and nutrition disorders
Appetite disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cachexia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Decreased appetite	1/4 (25%)	1	1/7 (14.3%)	1	5/9 (55.6%)	5	2/11 (18.2%)	2	5/15 (33.3%)	5	4/9 (44.4%)	4	4/7 (57.1%)	5	1/6 (16.7%)	1	3/14 (21.4%)	3	4/24 (16.7%)	4	6/20 (30%)	6	11/53 (20.8%)	13	8/22 (36.4%)	11	6/14 (42.9%)	6	3/10 (30%)	3	1/1 (100%)	2	1/1 (100%)	2	9/55 (16.4%)	9	4/50 (8%)	4
Dehydration	0/4 (0%)	0	2/7 (28.6%)	2	1/9 (11.1%)	2	1/11 (9.1%)	1	2/15 (13.3%)	2	2/9 (22.2%)	4	0/7 (0%)	0	2/6 (33.3%)	2	0/14 (0%)	0	1/24 (4.2%)	2	1/20 (5%)	1	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Dyslipidaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Failure to thrive	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Fluid overload	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Folate deficiency	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Gout	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Hypercalcaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	9/53 (17%)	10	3/22 (13.6%)	3	2/14 (14.3%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	6	2/50 (4%)	2
Hypercholesterolaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	4	1/50 (2%)	1
Hypercreatininaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hyperglycaemia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	2/20 (10%)	4	0/53 (0%)	0	1/22 (4.5%)	3	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	5	2/50 (4%)	3
Hyperkalaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Hyperlipidaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypernatraemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hyperphosphataemia	0/4 (0%)	0	0/7 (0%)	0	2/9 (22.2%)	2	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypertriglyceridaemia	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	1	2/53 (3.8%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	5
Hyperuricaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Hypoalbuminaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Hypocalcaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	2/9 (22.2%)	3	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	2/50 (4%)	2
Hypocholesterolaemia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypoglycaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypokalaemia	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	2/11 (18.2%)	2	2/15 (13.3%)	3	0/9 (0%)	0	2/7 (28.6%)	2	1/6 (16.7%)	1	2/14 (14.3%)	3	0/24 (0%)	0	0/20 (0%)	0	9/53 (17%)	17	3/22 (13.6%)	8	1/14 (7.1%)	1	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	6/55 (10.9%)	8	4/50 (8%)	5
Hypomagnesaemia	1/4 (25%)	2	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	3/53 (5.7%)	6	1/22 (4.5%)	1	0/14 (0%)	0	2/10 (20%)	2	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	3/50 (6%)	5
Hyponatraemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	2/11 (18.2%)	3	1/15 (6.7%)	1	2/9 (22.2%)	4	0/7 (0%)	0	0/6 (0%)	0	2/14 (14.3%)	3	2/24 (8.3%)	3	0/20 (0%)	0	7/53 (13.2%)	9	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	5/55 (9.1%)	6	7/50 (14%)	8
Hypophosphataemia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	2/15 (13.3%)	2	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	6/53 (11.3%)	7	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	3/50 (6%)	6
Iron deficiency	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Malnutrition	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Vitamin b12 deficiency	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Vitamin d deficiency	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	1/11 (9.1%)	2	3/15 (20%)	4	1/9 (11.1%)	1	1/7 (14.3%)	3	1/6 (16.7%)	1	1/14 (7.1%)	2	2/24 (8.3%)	4	1/20 (5%)	1	5/53 (9.4%)	5	5/22 (22.7%)	9	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	5	4/50 (8%)	4
Arthritis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Back pain	0/4 (0%)	0	1/7 (14.3%)	1	2/9 (22.2%)	2	0/11 (0%)	0	1/15 (6.7%)	1	3/9 (33.3%)	5	1/7 (14.3%)	1	0/6 (0%)	0	2/14 (14.3%)	2	3/24 (12.5%)	3	3/20 (15%)	4	4/53 (7.5%)	4	3/22 (13.6%)	3	0/14 (0%)	0	1/10 (10%)	1	1/1 (100%)	1	0/1 (0%)	0	5/55 (9.1%)	7	4/50 (8%)	4
Bone pain	1/4 (25%)	1	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Fistula	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	2	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Flank pain	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Groin pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypercreatinaemia	0/4 (0%)	0	1/7 (14.3%)	3	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Jaw fistula	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Joint effusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	2	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Joint swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Kyphosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Limb discomfort	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Muscle contracture	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Muscle haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Muscle spasms	0/4 (0%)	0	2/7 (28.6%)	2	0/9 (0%)	0	0/11 (0%)	0	3/15 (20%)	3	2/9 (22.2%)	3	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	3	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Muscle tightness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Muscular weakness	0/4 (0%)	0	0/7 (0%)	0	2/9 (22.2%)	2	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	1	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Musculoskeletal chest pain	1/4 (25%)	1	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	2/9 (22.2%)	3	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	0/53 (0%)	0	3/22 (13.6%)	3	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	2/55 (3.6%)	2	3/50 (6%)	3
Musculoskeletal discomfort	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Musculoskeletal pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	2	1/14 (7.1%)	1	0/24 (0%)	0	1/20 (5%)	1	4/53 (7.5%)	5	3/22 (13.6%)	3	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	2/50 (4%)	2
Musculoskeletal stiffness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Myalgia	1/4 (25%)	1	1/7 (14.3%)	2	2/9 (22.2%)	2	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	3	2/20 (10%)	2	2/53 (3.8%)	2	2/22 (9.1%)	3	3/14 (21.4%)	3	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Neck mass	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Neck pain	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	2/15 (13.3%)	3	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	3/24 (12.5%)	3	0/20 (0%)	0	7/53 (13.2%)	8	4/22 (18.2%)	4	2/14 (14.3%)	2	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	8	5/50 (10%)	5
Pain in extremity	0/4 (0%)	0	2/7 (28.6%)	3	2/9 (22.2%)	2	2/11 (18.2%)	2	1/15 (6.7%)	1	1/9 (11.1%)	2	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	1	1/20 (5%)	1	2/53 (3.8%)	2	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	4	2/50 (4%)	2
Pain in jaw	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	2/11 (18.2%)	2	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	2	2/22 (9.1%)	2	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	1/50 (2%)	1
Spinal pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Trismus	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Basal cell carcinoma	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Benign neoplasm of cervix uteri	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cancer pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Infected neoplasm	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Oropharyngeal neoplasm	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Tumour associated fever	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tumour haemorrhage	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	2/20 (10%)	2	0/53 (0%)	0	2/22 (9.1%)	2	3/14 (21.4%)	5	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Tumour pain	1/4 (25%)	1	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	3/24 (12.5%)	3	2/20 (10%)	3	3/53 (5.7%)	3	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	4	2/50 (4%)	2
Tumour ulceration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Nervous system disorders
Amnesia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ataxia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Balance disorder	1/4 (25%)	1	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Brain oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Burning sensation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Carotid artery stenosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Disturbance in attention	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Dizziness	1/4 (25%)	2	0/7 (0%)	0	1/9 (11.1%)	2	0/11 (0%)	0	0/15 (0%)	0	3/9 (33.3%)	4	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	1	2/20 (10%)	2	5/53 (9.4%)	6	3/22 (13.6%)	3	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	9	8/50 (16%)	10
Dizziness postural	0/4 (0%)	0	1/7 (14.3%)	1	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Drooling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dysaesthesia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dysarthria	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dysgeusia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Facial paralysis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Headache	2/4 (50%)	2	1/7 (14.3%)	1	1/9 (11.1%)	2	2/11 (18.2%)	2	1/15 (6.7%)	1	2/9 (22.2%)	2	0/7 (0%)	0	1/6 (16.7%)	1	1/14 (7.1%)	1	3/24 (12.5%)	4	0/20 (0%)	0	10/53 (18.9%)	20	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	1/1 (100%)	2	0/1 (0%)	0	10/55 (18.2%)	12	10/50 (20%)	11
Hypersomnia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypoaesthesia	0/4 (0%)	0	0/7 (0%)	0	2/9 (22.2%)	2	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Jugular vein occlusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Lethargy	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Memory impairment	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Migraine	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Neuralgia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Neuropathy peripheral	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	0/50 (0%)	0
Paraesthesia	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Peripheral sensory neuropathy	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Phantom limb syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Presyncope	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	0/50 (0%)	0
Restless legs syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Sciatica	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Sinus headache	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Somnolence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Speech disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Spinal cord oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Stupor	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Syncope	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	4	1/50 (2%)	1
Taste disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Tremor	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	2/14 (14.3%)	2	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Product Issues
Device leakage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Device occlusion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Psychiatric disorders
Adjustment disorder with depressed mood	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Anxiety	0/4 (0%)	0	1/7 (14.3%)	1	2/9 (22.2%)	2	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	2/7 (28.6%)	2	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	2/53 (3.8%)	3	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	2
Confusional state	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Delirium	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Depressed mood	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Depression	0/4 (0%)	0	1/7 (14.3%)	1	1/9 (11.1%)	1	0/11 (0%)	0	2/15 (13.3%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	3/53 (5.7%)	3	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	5/50 (10%)	5
Emotional distress	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hallucination	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Insomnia	0/4 (0%)	0	2/7 (28.6%)	2	0/9 (0%)	0	2/11 (18.2%)	2	1/15 (6.7%)	1	3/9 (33.3%)	3	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	3/53 (5.7%)	3	1/22 (4.5%)	1	3/14 (21.4%)	3	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	2/55 (3.6%)	2	7/50 (14%)	7
Irritability	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Mental status changes	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Restlessness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Sopor	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Suicidal ideation	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Azotaemia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Bladder discomfort	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Chronic kidney disease	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dysuria	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Haematuria	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	4	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Hydronephrosis	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Incontinence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Nephrolithiasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Nocturia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Pollakiuria	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	0/50 (0%)	0
Polyuria	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Proteinuria	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	2	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Renal failure	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	2	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Renal injury	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Urethral syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Urinary incontinence	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Urinary retention	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Reproductive system and breast disorders
Breast induration	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cervix inflammation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Cervix oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Ovarian cyst	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pelvic pain	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Prostatic obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pruritus genital	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Scrotal erythema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Scrotal haematocoele	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Scrotal swelling	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Vaginal disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Vulvovaginal pruritus	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Apnoeic attack	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Aspiration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Bronchial haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	2	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Bronchial secretion retention	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	0/50 (0%)	0
Bronchospasm	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	4	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Choking	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Chronic obstructive pulmonary disease	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	2/15 (13.3%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cough	2/4 (50%)	2	1/7 (14.3%)	3	2/9 (22.2%)	2	3/11 (27.3%)	4	3/15 (20%)	3	1/9 (11.1%)	1	1/7 (14.3%)	1	1/6 (16.7%)	1	1/14 (7.1%)	1	6/24 (25%)	6	5/20 (25%)	6	12/53 (22.6%)	15	6/22 (27.3%)	7	2/14 (14.3%)	2	1/10 (10%)	1	1/1 (100%)	3	1/1 (100%)	1	16/55 (29.1%)	17	1/50 (2%)	1
Dry throat	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dysphonia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	1	0/53 (0%)	0	1/22 (4.5%)	1	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	2
Dyspnoea	1/4 (25%)	1	2/7 (28.6%)	2	3/9 (33.3%)	3	4/11 (36.4%)	4	4/15 (26.7%)	4	2/9 (22.2%)	2	3/7 (42.9%)	3	0/6 (0%)	0	1/14 (7.1%)	1	5/24 (20.8%)	7	5/20 (25%)	5	16/53 (30.2%)	18	4/22 (18.2%)	5	5/14 (35.7%)	7	4/10 (40%)	6	0/1 (0%)	0	1/1 (100%)	1	8/55 (14.5%)	8	8/50 (16%)	9
Dyspnoea exertional	0/4 (0%)	0	1/7 (14.3%)	1	1/9 (11.1%)	1	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	2/14 (14.3%)	2	1/24 (4.2%)	1	0/20 (0%)	0	7/53 (13.2%)	7	1/22 (4.5%)	1	3/14 (21.4%)	3	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	2
Epiglottic oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Epistaxis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	2	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	1	2/53 (3.8%)	5	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	2/50 (4%)	3
Haemoptysis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	1	1/7 (14.3%)	1	1/6 (16.7%)	1	0/14 (0%)	0	4/24 (16.7%)	4	2/20 (10%)	2	5/53 (9.4%)	5	0/22 (0%)	0	2/14 (14.3%)	2	0/10 (0%)	0	1/1 (100%)	3	0/1 (0%)	0	3/55 (5.5%)	3	2/50 (4%)	2
Haemothorax	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hiccups	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hyperventilation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypoxia	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Increased bronchial secretion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Increased upper airway secretion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Increased viscosity of upper respiratory secretion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Laryngeal obstruction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Laryngeal oedema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	2/14 (14.3%)	2	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lung disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lung infiltration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Nasal cavity toxicity	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Nasal congestion	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	2	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Oropharyngeal pain	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	1	4/53 (7.5%)	6	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/55 (7.3%)	4	1/50 (2%)	2
Paranasal sinus discomfort	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Paranasal sinus hypersecretion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pharyngeal fistula	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pharyngeal haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pharyngeal ulceration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pleural effusion	0/4 (0%)	0	0/7 (0%)	0	2/9 (22.2%)	2	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	2	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	2/14 (14.3%)	2	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	5
Pleuritic pain	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	2	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pneumonia aspiration	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pneumonitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	5/55 (9.1%)	6	0/50 (0%)	0
Pneumothorax	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Productive cough	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	2/24 (8.3%)	3	1/20 (5%)	1	11/53 (20.8%)	13	2/22 (9.1%)	2	1/14 (7.1%)	1	2/10 (20%)	2	0/1 (0%)	0	0/1 (0%)	0	7/55 (12.7%)	10	5/50 (10%)	5
Pulmonary embolism	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Pulmonary thrombosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Respiratory failure	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Respiratory tract congestion	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Rhinalgia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Rhinitis allergic	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	2	0/50 (0%)	0
Rhinorrhoea	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	2/15 (13.3%)	2	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	2	4/53 (7.5%)	4	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Sinus congestion	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Sleep apnoea syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Sputum discoloured	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Sputum increased	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Sputum retention	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Throat irritation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	2
Throat tightness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Tracheal fistula	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Upper-airway cough syndrome	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Wheezing	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Actinic keratosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Alopecia	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Blister	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Cold sweat	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dandruff	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Decubitus ulcer	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Dermal cyst	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dermatitis	1/4 (25%)	1	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Dermatitis acneiform	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	2
Dermatitis contact	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Dry skin	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	3	2/22 (9.1%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Ecchymosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eczema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	2	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Eczema nummular	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Erythema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	3	2/20 (10%)	2	0/53 (0%)	0	4/22 (18.2%)	6	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	0/50 (0%)	0
Hyperhidrosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Hypertrophic scar	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Interstitial granulomatous dermatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Livedo reticularis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Lividity	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Nail bed bleeding	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Neurodermatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Night sweats	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Onychoclasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Pain of skin	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Perioral dermatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Petechiae	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	1	1/24 (4.2%)	3	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Photosensitivity reaction	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Pruritus	1/4 (25%)	1	1/7 (14.3%)	2	1/9 (11.1%)	3	1/11 (9.1%)	1	1/15 (6.7%)	1	4/9 (44.4%)	5	1/7 (14.3%)	1	1/6 (16.7%)	1	0/14 (0%)	0	3/24 (12.5%)	4	0/20 (0%)	0	8/53 (15.1%)	10	5/22 (22.7%)	7	1/14 (7.1%)	1	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	6/55 (10.9%)	6	7/50 (14%)	10
Pruritus generalised	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	1/22 (4.5%)	2	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Psoriasis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	2	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Purpura	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Rash	1/4 (25%)	1	0/7 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	1/15 (6.7%)	1	5/9 (55.6%)	5	0/7 (0%)	0	1/6 (16.7%)	1	1/14 (7.1%)	1	2/24 (8.3%)	2	3/20 (15%)	3	7/53 (13.2%)	9	4/22 (18.2%)	6	0/14 (0%)	0	1/10 (10%)	1	1/1 (100%)	1	0/1 (0%)	0	7/55 (12.7%)	12	6/50 (12%)	7
Rash erythematous	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	3/50 (6%)	3
Rash macular	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Rash maculo-papular	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	1/11 (9.1%)	1	2/15 (13.3%)	2	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	1/14 (7.1%)	5	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	2	0/22 (0%)	0	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	2/50 (4%)	2
Rash papular	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Rash pruritic	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	1/20 (5%)	1	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Scab	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin disorder	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Skin fissures	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Skin haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin hypopigmentation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin lesion	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	1/15 (6.7%)	1	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	2/53 (3.8%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin mass	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin tightness	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Skin toxicity	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Skin ulcer	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	1/50 (2%)	1
Stasis dermatitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Subcutaneous emphysema	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Swelling face	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	3/55 (5.5%)	3	1/50 (2%)	1
Urticaria	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Vascular disorders
Aneurysm	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Capillary fragility	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Deep vein thrombosis	0/4 (0%)	0	1/7 (14.3%)	1	1/9 (11.1%)	1	0/11 (0%)	0	1/15 (6.7%)	1	1/9 (11.1%)	1	0/7 (0%)	0	1/6 (16.7%)	1	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Embolism	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Haematoma	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	3	0/50 (0%)	0
Haemorrhage	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Hot flush	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	2/50 (4%)	2
Hypertension	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	1/24 (4.2%)	1	1/20 (5%)	2	8/53 (15.1%)	10	4/22 (18.2%)	7	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	2	0/1 (0%)	0	2/55 (3.6%)	3	3/50 (6%)	5
Hypertensive crisis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Hypotension	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	2/24 (8.3%)	4	1/20 (5%)	1	4/53 (7.5%)	5	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	3/55 (5.5%)	3	1/50 (2%)	2
Intermittent claudication	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Lymphoedema	0/4 (0%)	0	0/7 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	1/22 (4.5%)	1	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Orthostatic hypertension	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/55 (1.8%)	1	0/50 (0%)	0
Orthostatic hypotension	0/4 (0%)	0	1/7 (14.3%)	1	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/7 (0%)	0	0/6 (0%)	0	2/14 (14.3%)	3	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	1/22 (4.5%)	1	0/14 (0%)	0	1/10 (10%)	1	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Phlebitis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	2/53 (3.8%)	3	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Poor peripheral circulation	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Raynaud's phenomenon	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Subclavian artery stenosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	1/50 (2%)	1
Thrombophlebitis superficial	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/55 (3.6%)	2	0/50 (0%)	0
Thrombosis	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	1/53 (1.9%)	1	0/22 (0%)	0	0/14 (0%)	0	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0
Venous thrombosis limb	0/4 (0%)	0	0/7 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/15 (0%)	0	0/9 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/14 (0%)	0	0/24 (0%)	0	0/20 (0%)	0	0/53 (0%)	0	0/22 (0%)	0	1/14 (7.1%)	1	0/10 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/55 (0%)	0	0/50 (0%)	0

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