Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02460224
• Collaborator: (none)
• Enrollment: 490
• Locations: 24
• Arms: 29
• Actual Duration (Months): 66.5
• Patients Per Site: 20.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: LAG525; Drug: PDR001	Phase 1/Phase 2

Detailed Description

This was a Phase 1/2, multi-center, open-label study comprising a Phase 1 dose escalation part followed by a Phase 2 dose expansion part.

During the Phase 1 dose escalation part patients with any advanced solid tumor received the study treatment until the MTD was reached or a lower RP2D was established. The study had the following 3 dose escalation parts: 1) Single-agent LAG525; 2) Single-agent LAG525 in Japanese patients; 3) Combination of LAG525 with PDR001.

Once the RP2D or MTD had been determined in the escalation parts, additional patients were to be enrolled in the Phase 2 expansion parts in order to assess the preliminary anti-tumor activity. Phase 2 expansion cohorts testing single-agent LAG525 were not opened for enrollment based on emerging data including but not limited to preliminary anti-tumor activity. Phase 2 expansion cohorts for the combination of LAG525 with PDR001 were opened and 5 tumor types were assessed: 1) Non-small cell lung cancer (NSCLC); 2) Melanoma; 3) Renal cell cancer (RCC); 4) Mesothelioma; 5) Triple negative breast cancer (TNBC). The efficacy and safety of the combination of LAG525 with PDR001 in these tumor types was assessed in both the PD-1/PD-L1 pre-treated and naïve settings.

Study Design

• Study Type: Interventional
• Actual Enrollment: 490 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced Malignancies
• Actual Study Start Date: Jun 17, 2015
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1: LAG525 1 mg/kg Q2W Single-agent LAG525 1 mg/kg Q2W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 3 mg/kg Q2W Single-agent LAG525 3 mg/kg Q2W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 5 mg/kg Q2W Single-agent LAG525 5 mg/kg Q2W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 10 mg/kg Q2W Single-agent LAG525 10 mg/kg Q2W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 15 mg/kg Q2W Single-agent LAG525 15 mg/kg Q2W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 240 mg Q2W Single-agent LAG525 240 mg Q2W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 400 mg Q2W Single-agent LAG525 400 mg Q2W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 3 mg/kg Q4W Single-agent LAG525 3 mg/kg Q4W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 5 mg/kg Q4W Single-agent LAG525 5 mg/kg Q4W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 10 mg/kg Q4W Single-agent LAG525 10 mg/kg Q4W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 400 mg Q4W Single-agent LAG525 400 mg Q4W	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion
Experimental: Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion
Experimental: Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1	Drug: LAG525; LAG525 was administered via intravenous (i.v.) infusion; Drug: PDR001; PDR001 was administered via i.v. infusion

Outcome Measures

Primary Outcome Measures

1. Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) [15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms]

   A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

2. Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 [From start of treatment until end of treatment, assessed up to 2.6 years]

   Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.

Secondary Outcome Measures

1. Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.]

   Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.

2. Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.]

   Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type.

3. Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 [From start of treatment until end of treatment, assessed up to 4.4 years.]

   Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.

4. Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 [From start of treatment until end of treatment, assessed up to 2.6 years.]

   Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.

5. Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 [From start of treatment until end of treatment, assessed up to 4.4 years.]

   Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable.

6. Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 [From start of treatment until end of treatment, assessed up to 2.6 years.]

   Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). The RDI of both study drugs is reported for each tumor type.

7. Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

   Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

8. Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

   Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

9. Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

   Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

10. Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

11. Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.

12. Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.

13. Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.

14. Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.

15. Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.

16. Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

17. Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.

18. Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

19. Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.

20. Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.

21. Phase 1: Terminal Elimination Half-life (T1/2) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.

22. Phase 2: Terminal Elimination Half-life (T1/2) of PDR001 [pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).]

    Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.

23. Phase 1: Number of Participants With Anti-LAG525 Antibodies [Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).]

    Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.

24. Phase 2: Number of Participants With Anti-LAG525 Antibodies [Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).]

    Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.

25. Phase 1: Number of Participants With Anti-PDR001 Antibodies [Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).]

    Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.

26. Phase 2: Number of Participants With Anti-PDR001 Antibodies [Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).]

    Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.

27. Phase 1: Overall Response Rate (ORR) Per RECIST 1.1 [From start of treatment until end of treatment, assessed up to 4.4 years]

    Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.

28. Phase 1: Overall Response Rate (ORR) Per irRC [From start of treatment until end of treatment, assessed up to 4.4 years]

    TTumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.

29. Phase 2: Overall Response Rate (ORR) Per irRC [From start of treatment until end of treatment, assessed up to 2.6 years]

    Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.

30. Phase 1: Disease Control Rate (DCR) Per RECIST 1.1 [From start of treatment until end of treatment, assessed up to 4.4 years]

    Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.

31. Phase 1: Disease Control Rate (DCR) Per irRC [From start of treatment until end of treatment, assessed up to 4.4 years]

    Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.

32. Phase 2: Disease Control Rate (DCR) Per RECIST 1.1 [From start of treatment until end of treatment, assessed up to 2.6 years]

    Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.

33. Phase 2: Disease Control Rate (DCR) Per irRC [From start of treatment until end of treatment, assessed up to 2.6 years]

    Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.

34. Phase 1: Duration of Response (DOR) Per RECIST 1.1 [From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years]

    DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.

35. Phase 1: Duration of Response (DOR) Per irRC [From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years]

    DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC.

36. Phase 2: Duration of Response (DOR) Per RECIST 1.1 [From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years]

    DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. DOR is reported by tumor type.

37. Phase 2: Duration of Response (DOR) Per irRC [From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years]

    DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. DOR is reported by tumor type.

38. Phase 1: Progression-free Survival (PFS) Per RECIST 1.1 [From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years]

    PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported for ROW and Japanese patients.

39. Phase 1: Progression-free Survival (PFS) Per irRC [From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years]

    PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported for ROW and Japanese patients.

40. Phase 2: Progression-free Survival (PFS) Per RECIST 1.1 [From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years]

    PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported by tumor type.

41. Phase 2: Progression-free Survival (PFS) Per irRC [From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years]

    PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported by tumor type.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Phase I part:

• Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists

Phase II part:

• Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups:

• Group 1: NSCLC

• Group 2: Melanoma

• Group 3: Renal cancer

• Group 4: Mesothelioma

• Group 5: TNBC

• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

• Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy.

Exclusion Criteria:

• History of severe hypersensitivity reactions to study treatment ingredients or other mAbs

• Active, known or suspected autoimmune disease

• Active infection requiring systemic antibiotic therapy

• HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

• Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency

• Patients receiving systemic treatment with any immunosuppressive medication

• Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment

• Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment.

• Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks

• History of drug-induced pneumonitis or current pneumonitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center SC LAG X2101C	New York	New York	United States	10032
2	Memorial Sloan Kettering Cancer Center SC	New York	New York	United States	10065
3	Duke Clinical Research Institute SC	Durham	North Carolina	United States	27704
4	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
5	Cancer Therapy and Research Center UT Health Science Center CTRC 2	San Antonio	Texas	United States	78229
6	Huntsman Cancer Institute Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
7	Novartis Investigative Site	Westmead	New South Wales	Australia	2145
8	Novartis Investigative Site	Heidelberg	Victoria	Australia	3084
9	Novartis Investigative Site	Leuven		Belgium	3000
10	Novartis Investigative Site	Edmonton	Alberta	Canada	T6G 1Z2
11	Novartis Investigative Site	Toronto	Ontario	Canada	M5G 2M9
12	Novartis Investigative Site	Lyon Cedex		France	69373
13	Novartis Investigative Site	Saint-Herblain Cédex		France	44805
14	Novartis Investigative Site	Heidelberg		Germany	69120
15	Novartis Investigative Site	Wuerzburg		Germany	97080
16	Novartis Investigative Site	Hong Kong		Hong Kong
17	Novartis Investigative Site	Milano	MI	Italy	20133
18	Novartis Investigative Site	Modena	MO	Italy	41124
19	Novartis Investigative Site	Fukuoka-city	Fukuoka	Japan	811-1395
20	Novartis Investigative Site	Singapore		Singapore	119228
21	Novartis Investigative Site	Singapore		Singapore	169610
22	Novartis Investigative Site	Barcelona	Catalunya	Spain	08035
23	Novartis Investigative Site	Madrid		Spain	28009
24	Novartis Investigative Site	Taipei		Taiwan	10002

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - Jun 27, 2019
• Statistical Analysis Plan - Mar 15, 2021

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02460224
• Other Study ID Numbers: CLAG525X2101C; 2015-000449-21
• First Posted: Jun 2, 2015
• Last Update Posted: Feb 10, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: Non-small cell lung cancer; Melanoma; Renal cancer; Mesothelioma; Triple Negative Breast; TNBC; Renal
• Additional relevant MeSH terms: Neoplasms; Spartalizumab

Study Results

Participant Flow

Recruitment Details	Participants took part in 25 investigative sites in 12 countries.
Pre-assignment Detail	The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed ≤ 21 days before Cycle 1 Day 1, except for baseline radiological evaluations which had to be done within 28 days.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Period Title: Overall Study
STARTED	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6	121	21	93
Rest of the World Patients in the Dose Escalation Part	13	12	6	6	6	25	24	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6	0	0	0
Japanese Patients in the Dose Escalation Part	4	0	0	0	0	5	6	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6	121	21	93

Baseline Characteristics

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Total
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1	Total of all reporting groups
Overall Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6	121	21	93	490
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.1 (12.55)	64.5 (12.43)	61.8 (13.32)	53.3 (20.76)	61.2 (9.58)	57.2 (10.94)	56.7 (10.82)	60.8 (9.36)	54.8 (17.26)	59.5 (7.16)	60.4 (7.16)	54.3 (8.78)	58.0 (5.90)	44.8 (5.23)	58.2 (10.03)	48.7 (24.36)	59.1 (12.83)	61.2 (11.34)	61.3 (8.25)	51.1 (12.03)	59.8 (8.11)	51.8 (12.10)	59.2 (5.42)	56.6 (10.31)	60.7 (6.89)	52.3 (12.50)	61.0 (10.79)	49.4 (8.94)	58.4 (11.18)	58.1 (11.49)
Sex: Female, Male (Count of Participants)
Female	7 41.2%	6 50%	3 50%	4 66.7%	4 66.7%	17 56.7%	14 46.7%	2 40%	4 66.7%	6 54.5%	2 40%	3 50%	3 50%	2 33.3%	1 20%	3 50%	9 45%	3 50%	11 91.7%	3 42.9%	3 50%	7 58.3%	5 83.3%	6 54.5%	4 66.7%	3 50%	53 43.8%	20 95.2%	40 43%	248 50.6%
Male	10 58.8%	6 50%	3 50%	2 33.3%	2 33.3%	13 43.3%	16 53.3%	3 60%	2 33.3%	5 45.5%	3 60%	3 50%	3 50%	4 66.7%	4 80%	3 50%	11 55%	3 50%	1 8.3%	4 57.1%	3 50%	5 41.7%	1 16.7%	5 45.5%	2 33.3%	3 50%	68 56.2%	1 4.8%	53 57%	242 49.4%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	8 47.1%	9 75%	5 83.3%	3 50%	6 100%	20 66.7%	20 66.7%	2 40%	4 66.7%	10 90.9%	3 60%	2 33.3%	6 100%	6 100%	4 80%	5 83.3%	20 100%	6 100%	10 83.3%	7 100%	4 66.7%	8 66.7%	5 83.3%	9 81.8%	5 83.3%	6 100%	69 57%	15 71.4%	70 75.3%	347 70.8%
Black	1 5.9%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 4.8%	1 1.1%	4 0.8%
Asian	8 47.1%	2 16.7%	1 16.7%	3 50%	0 0%	10 33.3%	10 33.3%	1 20%	1 16.7%	0 0%	2 40%	3 50%	0 0%	0 0%	1 20%	1 16.7%	0 0%	0 0%	2 16.7%	0 0%	2 33.3%	2 16.7%	1 16.7%	2 18.2%	1 16.7%	0 0%	48 39.7%	4 19%	17 18.3%	122 24.9%
Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.1%	1 0.2%
Unknown	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	1 9.1%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 16.7%	0 0%	0 0%	0 0%	0 0%	2 1.7%	1 4.8%	4 4.3%	12 2.4%
Other	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 1.7%	0 0%	0 0%	4 0.8%

Outcome Measures

1. Primary Outcome

Title	Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Description	A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Time Frame	15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms. Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	16	12	6	5	6	28	27	5	6	11	5	6	6	5	5	5	17	4	9	5	6	11	6	11	5	6
Count of Participants [Participants]	1 5.9%	0 0%	2 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 9.1%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%	0 0%	1 16.7%	0 0%	1 16.7%	1 9.1%	0 0%	0 0%

2. Primary Outcome

Title	Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Description	Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.
Time Frame	From start of treatment until end of treatment, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
Non-small cell lung cancer (NSCLC)	15.0 88.2%	0 0%
Melanoma	15.0 88.2%	9.1 75.8%
Renal cell cancer (RCC)	26.3 154.7%	5.3 44.2%
Mesothelioma	17.1 100.6%	6.3 52.5%
Triple negative breast cancer (TNBC)	14.3 84.1%	4.8 40%	0 0%

3. Secondary Outcome

Title	Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
Time Frame	From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
AEs, ROW patients	13 76.5%	11 91.7%	6 100%	6 100%	6 100%	24 80%	24 80%	5 100%	6 100%	11 100%	5 100%	6 100%	6 100%	6 100%	5 100%	6 100%	19 95%	6 100%	12 100%	7 100%	6 100%	12 100%	6 100%	11 100%	6 100%	6 100%
SAEs, ROW patients	4 23.5%	2 16.7%	5 83.3%	2 33.3%	3 50%	10 33.3%	11 36.7%	2 40%	4 66.7%	5 45.5%	2 40%	3 50%	2 33.3%	3 50%	3 60%	1 16.7%	9 45%	3 50%	6 50%	4 57.1%	5 83.3%	5 41.7%	2 33.3%	5 45.5%	4 66.7%	4 66.7%
AEs, Japanese patients	4 23.5%	5 41.7%	6 100%
SAEs, Japanese patients	0 0%	2 16.7%	0 0%

4. Secondary Outcome

Title	Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type.
Time Frame	From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
AEs, Non-small cell lung cancer (NSCLC)	19 111.8%	22 183.3%
SAEs, Non-small cell lung cancer (NSCLC)	13 76.5%	7 58.3%
AEs, Melanoma	19 111.8%	22 183.3%
SAEs, Melanoma	8 47.1%	8 66.7%
AEs, Renal cell cancer (RCC)	19 111.8%	19 158.3%
SAEs, Renal cell cancer (RCC)	14 82.4%	5 41.7%
AEs, Mesothelioma	41 241.2%	16 133.3%
SAEs, Mesothelioma	15 88.2%	4 33.3%
AEs, Triple negative breast cancer (TNBC)	21 123.5%	21 175%	14 233.3%
SAEs, Triple negative breast cancer (TNBC)	9 52.9%	10 83.3%	4 66.7%

5. Secondary Outcome

Title	Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Description	Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.
Time Frame	From start of treatment until end of treatment, assessed up to 4.4 years.

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
LAG525 dose reduction, ROW patients	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 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%	0 0%	0 0%	0 0%	0 0%
LAG525 dose interruption, ROW patients	2 11.8%	2 16.7%	1 16.7%	1 16.7%	1 16.7%	1 3.3%	1 3.3%	1 20%	0 0%	2 18.2%	0 0%	4 66.7%	1 16.7%	2 33.3%	1 20%	1 16.7%	6 30%	2 33.3%	2 16.7%	1 14.3%	2 33.3%	3 25%	0 0%	4 36.4%	1 16.7%	1 16.7%
PDR001 dose reduction, ROW patients	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 20%	0 0%	0 0%	0 0%	0 0%
PDR001 dose interruption, ROW patients	4 23.5%	1 8.3%	2 33.3%	1 16.7%	0 0%	6 20%	2 6.7%	2 40%	1 16.7%	2 18.2%	3 60%	0 0%	3 50%	0 0%	1 20%
LAG525 dose reduction, Japanese patients	0 0%	0 0%	0 0%
LAG525 dose interruption, Japanese patients	0 0%	2 16.7%	2 33.3%

6. Secondary Outcome

Title	Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Description	Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.
Time Frame	From start of treatment until end of treatment, assessed up to 2.6 years.

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
LAG525 dose reduction, NSCLC patients	0 0%	0 0%
LAG525 dose interruption, NSCLC patients	3 17.6%	3 25%
PDR001 dose reduction, NSCLC patients	0 0%	0 0%
PDR001 dose interruption, NSCLC patients	3 17.6%	3 25%
LAG525 dose reduction, melanoma patients	0 0%	0 0%
LAG525 dose interruption, melanoma patients	4 23.5%	4 33.3%
PDR001 dose reduction, melanoma patients	0 0%	0 0%
PDR001 dose interruption, melanoma patients	4 23.5%	4 33.3%
LAG525 dose reduction, RCC patients	0 0%	0 0%
LAG525 dose interruption, RCC patients	5 29.4%	1 8.3%
PDR001 dose reduction, RCC patients	0 0%	0 0%
PDR001 dose interruption, RCC patients	5 29.4%	1 8.3%
LAG525 dose reduction, mesothelioma patients	0 0%	0 0%
LAG525 dose interruption, mesothelioma patients	8 47.1%	5 41.7%
PDR001 dose reduction, mesothelioma patients	0 0%	0 0%
PDR001 dose interruption, mesothelioma patients	8 47.1%	5 41.7%
LAG525 dose reduction, TNBC patients	0 0%	0 0%	0 0%
LAG525 dose interruption, TNBC patients	3 17.6%	0 0%	0 0%
PDR001 dose reduction, TNBC patients	0 0%	0 0%	0 0%
PDR001 dose interruption, TNBC patients	3 17.6%	0 0%	0 0%

7. Secondary Outcome

Title	Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
Description	Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable.
Time Frame	From start of treatment until end of treatment, assessed up to 4.4 years.

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
LAG525, ROW patients	98.9 (3.93)	100 (0)	94.4 (13.61)	100 (0)	98.2 (4.47)	99.0 (5.00)	99.9 (0.60)	100 (0)	100 (0)	100 (0)	100 (0)	97.4 (6.27)	100 (0)	99.7 (0.84)	100 (0)	99.6 (0.93)	97.8 (5.27)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	97.7 (7.54)	100 (0)	100 (0)
PDR001, ROW patients	97.3 (6.72)	100 (0)	97.6 (5.00)	100 (0)	100 (0)	98.0 (4.95)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)
LAG525, Japanese patients	100 (0)	98.0 (4.47)	100 (0)

8. Secondary Outcome

Title	Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
Description	Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). The RDI of both study drugs is reported for each tumor type.
Time Frame	From start of treatment until end of treatment, assessed up to 2.6 years.

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
LAG525, NSCLC patients	100 (0)	100 (0)
PDR001, NSCLC patients	100 (0)	99.8 (0.71)
LAG525, melanoma patients	99.4 (2.80)	99.7 (1.47)
PDR001, melanoma patients	99.4 (2.80)	99.7 (1.47)
LAG525, RCC patients	100 (0)	100 (0)
PDR001, RCC patients	100 (0)	100 (0)
LAG525, mesothelioma patients	99.3 (4.26)	99.4 (1.99)
PDR001, mesothelioma patients	99.3 (4.26)	99.4 (1.99)
LAG525, TNBC patients	96.5 (11.08)	100 (0)	100 (0)
PDR001, TNBC patients	98.4 (7.21)	100 (0)	100 (0)

9. Secondary Outcome

Title	Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	29	30	5	6	11	5	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	21.8 (6.52)	72.4 (14.1)	117 (26.7)	247 (63.2)	393 (95.2)	73.8 (19.2)	116 (28.3)	66.4 (14.1)	118 (23.8)	268 (38.5)	125 (38.9)	8.58 (2.53)	26.5 (3.6)	24.1 (6.58)	25.1 (6.81)	87.9 (24.7)	73.1 (14.7)	122 (36.4)	215 (43.9)	27.2 (5.51)	121 (8.96)	276 (66.5)	303 (82.3)	27.1 (7.56)	86.2 (22.2)	73.1 (42.2)
Cycle 3, ROW patients	34.7 (13.2)	124 (30.5)	272	306	607 (108)	114 (36.5)	169 (60.7)	77.9 (11)	117 (26.2)	222 (0)	250 (187)	9.57 (4.91)	31.6 (9.9)	35.2 (7.29)	33.8 (7.75)	156 (70.4)	88.7 (25.3)	114 (19.8)	274 (57.1)	32 (17)	174 (11.3)	354 (118)	513 (72.8)	33.3 (14.5)	96 (42.8)	147 (43)
Cycle 1, Japanese patients	23.1 (2.58)	95.5 (18.3)	152 (33.9)
Cycle 3, Japanese patients	32.6 (1.2)	198	255 (59.1)

10. Secondary Outcome

Title	Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	92
Cycle 1, NSCLC patients	154 (43.5)	106 (26.8)
Cycle 3, NSCLC patients	169 (51.9)	137 (30.8)
Cycle 1, melanoma patients	115 (29.9)	102 (36.7)
Cycle 3, melanoma patients	171 (32)	163 (52.8)
Cycle 1, RCC patients	118 (34.7)	111 (28.3)
Cycle 3, RCC patients	158 (45.4)	153 (43.5)
Cycle 1, mesothelioma patients	116 (31)	119 (37.6)
Cycle 3, mesothelioma patients	141 (39.7)	138 (33.1)
Cycle 1, TNBC patients	144 (32.4)	207 (53.1)	132 (26.7)
Cycle 3, TNBC patients	179 (65.2)	190 (55)	157 (33.2)

11. Secondary Outcome

Title	Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	29	30	5	6	11	5	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	1.73	1.6	1.63	1.63	1.99	1.59	1.57	1.58	2.1	2.02	1.5	1.5	1.5	1.5	1.53	1.55	1.52	1.5	1.57	1.52	1.5	1.58	1.58	1.5	1.7	1.5
Cycle 3, ROW patients	1.83	2.05	1.08	1.55	1.67	1.58	1.5	2.08	1.93	1.83	1.5	1.72	1.51	1.5	1.5	1.53	1.53	1.58	1.52	1.58	1.54	1.58	1.75	1.53	1.58	1.58
Cycle 1, Japanese patients	1.58	1.54	1.54
Cycle 3, Japanese patients	1.63	1.57	1.6

12. Secondary Outcome

Title	Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	92
Cycle 1, NSCLC patients	1.53	1.55
Cycle 3, NSCLC patients	1.55	1.58
Cycle 1, melanoma patients	1.51	1.53
Cycle 3, melanoma patients	1.53	1.53
Cycle 1, RCC patients	1.51	1.53
Cycle 3, RCC patients	1.58	1.53
Cycle 1, mesothelioma patients	1.53	1.55
Cycle 3, mesothelioma patients	1.5	1.52
Cycle 1, TNBC patients	1.53	1.53	1.58
Cycle 3, TNBC patients	1.63	1.78	1.6

13. Secondary Outcome

Title	Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	29	30	5	6	11	5	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	136 (49.2)	506 (111)	758 (172)	1830 (627)	2810 (555)	500 (147)	708 (199)	631 (184)	1220 (491)	2230 (731)	1290 (537)	35.8 (10.5)	174 (31.3)	138 (38.9)	162 (56.5)	588 (196)	608 (165)	952 (441)	1640 (539)	198 (101)	1040 (183)	2890 (982)	3020 (928)	150 (61.6)	484 (173)	551 (205)
Cycle 3, ROW patients	264 (146)	1000 (358)	2470	2330	5270 (1250)	862 (583)	1390 (759)	928 (469)	1200 (754)	1770 (2230)	2740 (2680)	59.9 (39.3)	286 (134)	264 (133)	234 (108)	1310 (701)	869 (328)	1410 (831)	1990 (1180)	336 (439)	2250 (44.7)	3840 (1600)	7160 (3190)	211 (150)	938 (141)	1230 (617)
Cycle 1, Japanese patients	144 (35.6)	679 (142)	1130 (153)
Cycle 3, Japanese patients	89.6 (76.7)	1720	2520 (359)

14. Secondary Outcome

Title	Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	92
Cycle 1, NSCLC patients	1260 (509)	955 (272)
Cycle 3, NSCLC patients	1500 (688)	1260 (554)
Cycle 1, melanoma patients	1030 (404)	953 (340)
Cycle 3, melanoma patients	1860 (507)	1680 (754)
Cycle 1, RCC patients	979 (366)	886 (429)
Cycle 3, RCC patients	1420 (678)	1280 (809)
Cycle 1, mesothelioma patients	963 (329)	1070 (350)
Cycle 3, mesothelioma patients	1400 (732)	1380 (729)
Cycle 1, TNBC patients	1180 (379)	2010 (807)	1150 (234)
Cycle 3, TNBC patients	1710 (1090)	2800 (1210)	1530 (578)

15. Secondary Outcome

Title	Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	29	30	5	6	11	5	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	7.65 (1.94)	11.1 (4.12)	9.99 (2.37)	12 (4.5)	12.8 (8)	10.3 (3.5)	11.5 (6.59)	13.5 (4.07)	13.1 (5.38)	13.9 (5.15)	13.6 (7.61)	3.47 (1.4)	9.15 (3.86)	6.5 (3.25)	7.52 (2.5)	9.5 (2.78)	11.5 (3.7)	11.3 (4.94)	10.2 (3.68)	7.49 (4.42)	15.7 (4.23)	17.9 (7.88)	14.4 (3.28)	5.26 (2.43)	9.12 (2.07)	9.36 (2.18)
Cycle 3, ROW patients	11.2 (2.62)	14.4 (5.82)	5.94	12.2	16.5 (2.87)	12.1 (5.06)	18 (9.7)	15 (2.36)	20.6 (8.51)	20.8	23.4 (14.6)	6.15 (2.98)	9.55 (3.95)	9.17 (4.36)	13.1 (0.736)	14.7	14.3 (7.02)	14.5 (1.24)	13.8 (4.45)	11.1 (10.9)	18.3 (3.58)	15.1 (5.44)	26.3 (11.9)	7.32 (4.94)	10.8 (1.76)	15.1 (4.54)
Cycle 1, Japanese patients	13.7 (10.2)	9.42 (2.27)	13.8 (4.38)
Cycle 3, Japanese patients	5.49 (2.38)	19.4	28.1 (18)

16. Secondary Outcome

Title	Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Description	Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 and had a valid measure of the endpoint.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	84	13	64
Cycle 1, NSCLC patients	11.6 (6.11)	13.3 (4.62)
Cycle 3, NSCLC patients	16.3 (9.17)	15.9 (7.88)
Cycle 1, melanoma patients	15.6 (5.18)	15.5 (5.92)
Cycle 3, melanoma patients	20.1 (5.24)	19.2 (9.26)
Cycle 1, RCC patients	14.2 (3.61)	14.1 (5.39)
Cycle 3, RCC patients	14.1 (3.71)	23.1 (6.33)
Cycle 1, mesothelioma patients	13 (5.13)	13.7 (5.27)
Cycle 3, mesothelioma patients	18.4 (7.16)	18.7 (5.47)
Cycle 1, TNBC patients	22.5 (18.9)	14.6 (3.82)	14.4 (5.01)
Cycle 3, TNBC patients	18.7 (9.14)	19 (4.78)

17. Secondary Outcome

Title	Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	19.6 (3.59)	19.6 (2.77)	17.7 (3.84)	58.8 (23.2)	67.9 (20.4)	76.2 (20)	61.5 (22.1)	85.1 (28)	65 (11.3)	87.6 (24.5)	113 (26.8)	116 (28.1)	100 (23.1)	115 (33.2)	97.9 (17)
Cycle 3, ROW patients	30.4 (11.9)	28.7 (8.4)	29.7 (9.97)	89.5 (28.9)	168 (20.1)	97.5 (34.4)	80 (25.1)	123 (35.6)	90.8 (51.2)	142	134 (56.7)	167 (9.9)	141 (58.2)	147 (29.8)	126 (27.2)

18. Secondary Outcome

Title	Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	92
Cycle 1, NSCLC patients	102 (33)	68.9 (17.3)
Cycle 3, NSCLC patients	118 (36.5)	100 (24.2)
Cycle 1, melanoma patients	75.7 (25.2)	71.3 (26.2)
Cycle 3, melanoma patients	117 (29.8)	105 (43.3)
Cycle 1, RCC patients	81 (21.3)	67 (25.8)
Cycle 3, RCC patients	104 (23.8)	103 (36.1)
Cycle 1, mesothelioma patients	70.5 (21.4)	82.7 (39)
Cycle 3, mesothelioma patients	96.5 (31.5)	113 (36.8)
Cycle 1, TNBC patients	91.5 (25.1)	117 (36.7)	89.8 (14.8)
Cycle 3, TNBC patients	124 (36.5)	134 (54)	123 (18.5)

19. Secondary Outcome

Title	Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	1.5	1.5	1.55	1.63	1.51	1.53	1.75	1.53	1.58	1.5	1.66	1.5	1.5	1.58	1.56
Cycle 3, ROW patients	1.5	1.58	1.55	1.72	1.75	1.5	1.5	1.58	1.63	1.8	1.53	1.87	1.55	1.55	1.58

20. Secondary Outcome

Title	Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	92
Cycle 1, NSCLC patients	1.57	1.57
Cycle 3, NSCLC patients	1.57	1.58
Cycle 1, melanoma patients	1.55	1.53
Cycle 3, melanoma patients	1.57	1.53
Cycle 1, RCC patients	1.58	1.57
Cycle 3, RCC patients	1.53	1.58
Cycle 1, mesothelioma patients	1.55	1.54
Cycle 3, mesothelioma patients	1.52	1.5
Cycle 1, TNBC patients	1.58	1.57	1.53
Cycle 3, TNBC patients	1.6	1.75	1.65

21. Secondary Outcome

Title	Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	114 (17)	141 (45.4)	134 (25.7)	437 (177)	466 (159)	601 (238)	537 (163)	637 (263)	591 (207)	789 (319)	1290 (441)	1190 (353)	1080 (412)	1110 (335)	950 (264)
Cycle 3, ROW patients	292 (131)	268 (151)	289 (196)	816 (472)	1340 (673)	1180 (447)	1020 (563)	939 (572)	1500 (1450)	1860 (150)	1950 (645)	2840 (531)	1440 (828)	1510 (874)	1310 (700)

22. Secondary Outcome

Title	Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	92
Cycle 1, NSCLC patients	853 (347)	629 (197)
Cycle 3, NSCLC patients	1020 (500)	881 (443)
Cycle 1, melanoma patients	663 (291)	633 (310)
Cycle 3, melanoma patients	1390 (406)	1070 (537)
Cycle 1, RCC patients	739 (227)	617 (347)
Cycle 3, RCC patients	879 (547)	1060 (464)
Cycle 1, mesothelioma patients	633 (263)	747 (388)
Cycle 3, mesothelioma patients	1110 (500)	1110 (606)
Cycle 1, TNBC patients	808 (331)	1110 (621)	766 (277)
Cycle 3, TNBC patients	1370 (570)	2150 (1180)	1360 (351)

23. Secondary Outcome

Title	Phase 1: Terminal Elimination Half-life (T1/2) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	6	6	6	5	6	20	5	11	7	4	10	6	11	6	6
Cycle 1, ROW patients	9.71 (8.24)	10.2 (4.81)	12.5 (3.38)	20.7 (8.72)	30.8 (47)	22.8 (13.8)	14.8 (4.78)	11.8 (5)	14 (3.72)	15.1 (10.2)	20.4 (8.41)	18.7 (7.18)	20.4 (10)	14.6 (5.48)	17.3 (2.76)
Cycle 3, ROW patients	21.4 (9.4)	22.3 (7.13)	12.4 (10.3)	17.8 (5.03)	44.4 (36.8)	27.7 (19.4)	27.4 (4.25)	17.4 (5.64)	20.8 (12.4)	22.4	21.9 (4.22)	32.8 (12.5)	16.7 (10.2)	16.1 (5.64)	24.9 (6.75)

24. Secondary Outcome

Title	Phase 2: Terminal Elimination Half-life (T1/2) of PDR001
Description	Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time Frame	pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of PDR001 and had a valid measure of the endpoint.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	89	15	61
Cycle 1, NSCLC patients	17.2 (10)	15.8 (5.65)
Cycle 3, NSCLC patients	16.8 (7.88)	24.5 (8.47)
Cycle 1, melanoma patients	29.1 (31.6)	20 (5.66)
Cycle 3, melanoma patients	24.2 (6.17)	25.6 (15.7)
Cycle 1, RCC patients	17.8 (4.77)	18.4 (7.3)
Cycle 3, RCC patients	18.4 (5.02)	24.2 (5.05)
Cycle 1, mesothelioma patients	19.1 (7.98)	25.6 (7.49)
Cycle 3, mesothelioma patients	25.2 (14.5)	17.3 (8.11)
Cycle 1, TNBC patients	18.8 (8.33)	21.3 (7.43)	19.9 (6.24)
Cycle 3, TNBC patients	23.9 (17.1)	22.2 (0.591)	23.8 (5.64)

25. Secondary Outcome

Title	Phase 1: Number of Participants With Anti-LAG525 Antibodies
Description	Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time Frame	Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable. Japanese patients were analyzed together with the rest of the world (ROW) patients.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	14	11	4	5	6	21	17	4	6	7	5	5	6	5	5	5	15	3	8	6	3	9	5	10	6	5
ADA-negative at baseline	14 82.4%	10 83.3%	4 66.7%	5 83.3%	5 83.3%	19 63.3%	15 50%	3 60%	6 100%	6 54.5%	5 100%	5 83.3%	5 83.3%	5 83.3%	4 80%	4 66.7%	12 60%	3 50%	8 66.7%	6 85.7%	3 50%	9 75%	5 83.3%	10 90.9%	5 83.3%	5 83.3%
ADA-positive at post-baseline	6 35.3%	0 0%	2 33.3%	1 16.7%	0 0%	2 6.7%	0 0%	2 40%	0 0%	0 0%	2 40%	3 50%	1 16.7%	2 33.3%	2 40%	1 16.7%	1 5%	1 16.7%	1 8.3%	4 57.1%	0 0%	0 0%	0 0%	5 45.5%	1 16.7%	1 16.7%

26. Secondary Outcome

Title	Phase 2: Number of Participants With Anti-LAG525 Antibodies
Description	Validated immunoassays were used for screening and confirmation of the presence of anti-LAG525 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time Frame	Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	106	16	80
ADA-negative at baseline, NSCLC patients	19 111.8%	19 158.3%
ADA-positive at post-baseline, NSCLC patients	4 23.5%	2 16.7%
ADA-negative at baseline, melanoma patients	15 88.2%	19 158.3%
ADA-positive at post-baseline, melanoma patients	1 5.9%	0 0%
ADA-negative at baseline, RCC patients	17 100%	13 108.3%
ADA-positive at post-baseline, RCC patients	0 0%	1 8.3%
ADA-negative at baseline, mesothelioma patients	35 205.9%	13 108.3%
ADA-positive at post-baseline, mesothelioma patients	3 17.6%	1 8.3%
ADA-negative at baseline, TNBC patients	15 88.2%	15 125%	11 183.3%
ADA-positive at post-baseline, TNBC patients	2 11.8%	0 0%	1 16.7%

27. Secondary Outcome

Title	Phase 1: Number of Participants With Anti-PDR001 Antibodies
Description	Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time Frame	Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of PDR001 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	5	6	5	5	5	16	2	7	7	4	5	2	6	4	3
ADA-negative at baseline	5 29.4%	6 50%	5 83.3%	4 66.7%	5 83.3%	14 46.7%	2 6.7%	7 140%	7 116.7%	4 36.4%	5 100%	2 33.3%	6 100%	3 50%	3 60%
ADA-positive at post-baseline (i.e. ADA incidence)	2 11.8%	2 16.7%	2 33.3%	0 0%	2 33.3%	2 6.7%	0 0%	2 40%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	1 16.7%	0 0%

28. Secondary Outcome

Title	Phase 2: Number of Participants With Anti-PDR001 Antibodies
Description	Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.
Time Frame	Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 2.6 years).

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	108	14	82
ADA-negative at baseline, NSCLC patients	18 105.9%	21 175%
ADA-positive at post-baseline, NSCLC patients	6 35.3%	4 33.3%
ADA-negative at baseline, melanoma patients	16 94.1%	19 158.3%
ADA-positive at post-baseline, melanoma patients	5 29.4%	0 0%
ADA-negative at baseline, RCC patients	17 100%	12 100%
ADA-positive at post-baseline, RCC patients	2 11.8%	0 0%
ADA-negative at baseline, mesothelioma patients	32 188.2%	11 91.7%
ADA-positive at post-baseline, mesothelioma patients	6 35.3%	2 16.7%
ADA-negative at baseline, TNBC patients	17 100%	13 108.3%	9 150%
ADA-positive at post-baseline, TNBC patients	5 29.4%	1 8.3%	0 0%

29. Secondary Outcome

Title	Phase 1: Overall Response Rate (ORR) Per RECIST 1.1
Description	Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.
Time Frame	From start of treatment until end of treatment, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
ROW	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	33.3 555%	0 0%	16.7 278.3%	0 0%	16.7 278.3%	20.0 100%	33.3 555%	0 0%	0 0%	0 0%	16.7 139.2%	0 0%	0 0%	16.7 278.3%	0 0%
Japanese	0 0%	0 0%	0 0%

30. Secondary Outcome

Title	Phase 1: Overall Response Rate (ORR) Per irRC
Description	TTumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters. ORR is reported for ROW and Japanese patients.
Time Frame	From start of treatment until end of treatment, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
ROW	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	33.3 555%	0 0%	16.7 278.3%	0 0%	16.7 278.3%	20.0 100%	33.3 555%	0 0%	0 0%	0 0%	33.3 277.5%	0 0%	0 0%	16.7 278.3%	0 0%
Japanese	0 0%	0 0%	0 0%

31. Secondary Outcome

Title	Phase 2: Overall Response Rate (ORR) Per irRC
Description	Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.
Time Frame	From start of treatment until end of treatment, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
Non-small cell lung cancer (NSCLC)	15.0 88.2%	0 0%
Melanoma	15.0 88.2%	9.1 75.8%
Renal cell cancer (RCC)	26.3 154.7%	5.3 44.2%
Mesothelioma	19.5 114.7%	6.3 52.5%
Triple negative breast cancer (TNBC)	14.3 84.1%	4.8 40%	0 0%

32. Secondary Outcome

Title	Phase 1: Disease Control Rate (DCR) Per RECIST 1.1
Description	Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.
Time Frame	From start of treatment until end of treatment, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
ROW	23.1 135.9%	41.7 347.5%	16.7 278.3%	0 0%	66.7 1111.7%	24.0 80%	20.8 69.3%	20.0 400%	33.3 555%	18.2 165.5%	20.0 400%	50.0 833.3%	33.3 555%	33.3 555%	60.0 1200%	33.3 555%	55.0 275%	50.0 833.3%	8.3 69.2%	28.6 408.6%	66.7 1111.7%	41.7 347.5%	16.7 278.3%	36.4 330.9%	50.0 833.3%	50.0 833.3%
Japanese	25.0 147.1%	40.0 333.3%	16.7 278.3%

33. Secondary Outcome

Title	Phase 1: Disease Control Rate (DCR) Per irRC
Description	Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported for ROW and Japanese patients.
Time Frame	From start of treatment until end of treatment, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
ROW	30.8 181.2%	33.3 277.5%	16.7 278.3%	0 0%	50.0 833.3%	28.0 93.3%	33.3 111%	20.0 400%	33.3 555%	18.2 165.5%	20.0 400%	50.0 833.3%	66.7 1111.7%	50.0 833.3%	60.0 1200%	33.3 555%	55.0 275%	50.0 833.3%	8.3 69.2%	28.6 408.6%	66.7 1111.7%	50.0 416.7%	33.3 555%	36.4 330.9%	50.0 833.3%	50.0 833.3%
Japanese	25.0 147.1%	40.0 333.3%	16.7 278.3%

34. Secondary Outcome

Title	Phase 2: Disease Control Rate (DCR) Per RECIST 1.1
Description	Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.
Time Frame	From start of treatment until end of treatment, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
Non-small cell lung cancer (NSCLC)	50.0 294.1%	50.0 416.7%
Melanoma	45.0 264.7%	40.9 340.8%
Renal cell cancer (RCC)	63.2 371.8%	42.1 350.8%
Mesothelioma	65.9 387.6%	56.3 469.2%
Triple negative breast cancer (TNBC)	33.3 195.9%	23.8 198.3%	21.4 356.7%

35. Secondary Outcome

Title	Phase 2: Disease Control Rate (DCR) Per irRC
Description	Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). DCR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR), immune related Partial Response (irPR) or immune related Stable Disease (irSD). For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for irPR or irCR nor an increase in lesions which would qualify for progression. DCR is reported by tumor type.
Time Frame	From start of treatment until end of treatment, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
Non-small cell lung cancer (NSCLC)	60.0 352.9%	50.0 416.7%
Melanoma	55.0 323.5%	40.9 340.8%
Renal cell cancer (RCC)	68.4 402.4%	42.1 350.8%
Mesothelioma	65.9 387.6%	56.3 469.2%
Triple negative breast cancer (TNBC)	33.3 195.9%	28.6 238.3%	21.4 356.7%

36. Secondary Outcome

Title	Phase 1: Duration of Response (DOR) Per RECIST 1.1
Description	DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1.
Time Frame	From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0	1	4	2	0	0	0	2	0	0	1	0
Median (90% Confidence Interval) [months]	NA	NA	12.2	NA	18.4	6.5	NA

37. Secondary Outcome

Title	Phase 1: Duration of Response (DOR) Per irRC
Description	DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC.
Time Frame	From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (irCR or irPR).

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0	1	4	2	0	0	0	4	0	0	1	0
Median (90% Confidence Interval) [months]	NA	NA	12.2	NA	NA	9.2	NA

38. Secondary Outcome

Title	Phase 2: Duration of Response (DOR) Per RECIST 1.1
Description	DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. DOR is reported by tumor type.
Time Frame	From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	21	1	4
Non-small cell lung cancer (NSCLC)	5.0
Melanoma	11.0	NA
Renal cell cancer (RCC)	NA	NA
Mesothelioma	NA	NA
Triple negative breast cancer (TNBC)	NA	NA

39. Secondary Outcome

Title	Phase 2: Duration of Response (DOR) Per irRC
Description	DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. DOR is reported by tumor type.
Time Frame	From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (irCR or irPR).

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	22	1	4
Non-small cell lung cancer (NSCLC)	NA
Melanoma	17.5	NA
Renal cell cancer (RCC)	NA	NA
Mesothelioma	NA	NA
Triple negative breast cancer (TNBC)	NA	NA

40. Secondary Outcome

Title	Phase 1: Progression-free Survival (PFS) Per RECIST 1.1
Description	PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported for ROW and Japanese patients.
Time Frame	From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
ROW	1.8	2.3	1.6	1.9	7.9	1.7	1.8	2.8	2.1	1.8	1.5	3.8	1.9	1.8	8.4	1.8	2.8	6.5	1.4	1.8	3.1	2.3	1.5	1.9	3.8	3.2
Japanese	1.8	1.8	1.7

41. Secondary Outcome

Title	Phase 1: Progression-free Survival (PFS) Per irRC
Description	PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported for ROW and Japanese patients.
Time Frame	From start of treatment to first documented progression or death due to any cause, assessed up to 4.4 years

Outcome Measure Data

Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W	Phase 1: LAG525 3 mg/kg Q2W	Phase 1: LAG525 5 mg/kg Q2W	Phase 1: LAG525 10 mg/kg Q2W	Phase 1: LAG525 15 mg/kg Q2W	Phase 1: LAG525 240 mg Q2W	Phase 1: LAG525 400 mg Q2W	Phase 1: LAG525 3 mg/kg Q4W	Phase 1: LAG525 5 mg/kg Q4W	Phase 1: LAG525 10 mg/kg Q4W	Phase 1: LAG525 400 mg Q4W	Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W	Single-agent LAG525 3 mg/kg Q2W	Single-agent LAG525 5 mg/kg Q2W	Single-agent LAG525 10 mg/kg Q2W	Single-agent LAG525 15 mg/kg Q2W	Single-agent LAG525 240 mg Q2W	Single-agent LAG525 400 mg Q2W	Single-agent LAG525 3 mg/kg Q4W	Single-agent LAG525 5 mg/kg Q4W	Single-agent LAG525 10 mg/kg Q4W	Single-agent LAG525 400 mg Q4W	Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)	Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)	Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)	Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)	Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)	Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)	Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Measure Participants	17	12	6	6	6	30	30	5	6	11	5	6	6	6	5	6	20	6	12	7	6	12	6	11	6	6
ROW	1.9	1.9	1.6	1.9	3.4	1.8	1.9	2.8	2.6	1.8	1.5	3.8	4.2	2.6	8.4	1.8	2.8	7.5	1.6	2.0	3.1	3.2	1.5	2.0	3.8	3.2
Japanese	1.8	1.8	1.7

42. Secondary Outcome

Title	Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
Description	PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported by tumor type.
Time Frame	From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
Non-small cell lung cancer (NSCLC)	3.9	3.5
Melanoma	2.2	1.9
Renal cell cancer (RCC)	4.4	3.0
Mesothelioma	5.5	3.4
Triple negative breast cancer (TNBC)	1.9	1.8	1.7

43. Secondary Outcome

Title	Phase 2: Progression-free Survival (PFS) Per irRC
Description	PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was irRC. PFS is reported by tumor type.
Time Frame	From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years

Outcome Measure Data

Analysis Population Description

All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.

Arm/Group Title	Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W	Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W	Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Arm/Group Description	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1	Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Measure Participants	121	21	93
Non-small cell lung cancer (NSCLC)	4.2	3.5
Melanoma	5.4	1.9
Renal cell cancer (RCC)	5.8	3.0
Mesothelioma	5.6	3.4
Triple negative breast cancer (TNBC)	1.9	1.9	1.7

Adverse Events

Time Frame	From first dose of study treatment until last dose of study treatment plus 30 days, up to maximum 4.5 years (phase 1) and 2.7 years (phase 2).
Adverse Event Reporting Description	Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
Arm/Group Title	Phase 1: LAG525 1 mg/kg Q2W		Phase 1: LAG525 3 mg/kg Q2W		Phase 1: LAG525 5 mg/kg Q2W		Phase 1: LAG525 10 mg/kg Q2W		Phase 1: LAG525 15 mg/kg Q2W		Phase 1: LAG525 240 mg Q2W		Phase 1: LAG525 400 mg Q2W		Phase 1: LAG525 1 mg/kg Q2W-JP		Phase 1: LAG525 240 mg Q2W-JP		Phase 1: LAG525 400 mg Q2W-JP		Phase 1: LAG525 3 mg/kg Q4W		Phase 1: LAG525 5 mg/kg Q4W		Phase 1: LAG525 10 mg/kg Q4W		Phase 1: LAG525 400 mg Q4W		Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W		Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W		Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W		Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		All Patients
Arm/Group Description	Single-agent LAG525 1 mg/kg Q2W (ROW patients)		Single-agent LAG525 3 mg/kg Q2W		Single-agent LAG525 5 mg/kg Q2W		Single-agent LAG525 10 mg/kg Q2W		Single-agent LAG525 15 mg/kg Q2W		Single-agent LAG525 240 mg Q2W (ROW patients)		Single-agent LAG525 400 mg Q2W (ROW patients)		Single-agent LAG525 1 mg/kg Q2W (Japanese patients)		Single-agent LAG525 240 mg Q2W (Japanese patients)		Single-agent LAG525 400 mg Q2W (Japanese patients)		Single-agent LAG525 3 mg/kg Q4W		Single-agent LAG525 5 mg/kg Q4W		Single-agent LAG525 10 mg/kg Q4W		Single-agent LAG525 400 mg Q4W		Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)		Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)		Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)		Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)		Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)		Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)		Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)		Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)		Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)		Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)		Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)		Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)		Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)		Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC naïve to anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma naïve to anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC naïve to anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma naïve to anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC naïve to anti-PD-1/PD-L1		Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients with TNBC naïve to anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with NSCLC pre-treated with anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with melanoma pre-treated with anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with RCC pre-treated with anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with mesothelioma pre-treated with anti-PD-1/PD-L1		Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients with TNBC pre-treated with anti-PD-1/PD-L1		All patients
All Cause Mortality
	Phase 1: LAG525 1 mg/kg Q2W		Phase 1: LAG525 3 mg/kg Q2W		Phase 1: LAG525 5 mg/kg Q2W		Phase 1: LAG525 10 mg/kg Q2W		Phase 1: LAG525 15 mg/kg Q2W		Phase 1: LAG525 240 mg Q2W		Phase 1: LAG525 400 mg Q2W		Phase 1: LAG525 1 mg/kg Q2W-JP		Phase 1: LAG525 240 mg Q2W-JP		Phase 1: LAG525 400 mg Q2W-JP		Phase 1: LAG525 3 mg/kg Q4W		Phase 1: LAG525 5 mg/kg Q4W		Phase 1: LAG525 10 mg/kg Q4W		Phase 1: LAG525 400 mg Q4W		Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W		Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W		Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W		Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		All Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		5/25 (20%)		3/24 (12.5%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		2/12 (16.7%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/20 (5%)		3/20 (15%)		2/19 (10.5%)		1/41 (2.4%)		1/21 (4.8%)		1/21 (4.8%)		1/22 (4.5%)		1/22 (4.5%)		0/19 (0%)		2/16 (12.5%)		1/14 (7.1%)		33/490 (6.7%)
Serious Adverse Events
	Phase 1: LAG525 1 mg/kg Q2W		Phase 1: LAG525 3 mg/kg Q2W		Phase 1: LAG525 5 mg/kg Q2W		Phase 1: LAG525 10 mg/kg Q2W		Phase 1: LAG525 15 mg/kg Q2W		Phase 1: LAG525 240 mg Q2W		Phase 1: LAG525 400 mg Q2W		Phase 1: LAG525 1 mg/kg Q2W-JP		Phase 1: LAG525 240 mg Q2W-JP		Phase 1: LAG525 400 mg Q2W-JP		Phase 1: LAG525 3 mg/kg Q4W		Phase 1: LAG525 5 mg/kg Q4W		Phase 1: LAG525 10 mg/kg Q4W		Phase 1: LAG525 400 mg Q4W		Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W		Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W		Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W		Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		All Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	4/13 (30.8%)		2/12 (16.7%)		5/6 (83.3%)		2/6 (33.3%)		3/6 (50%)		10/25 (40%)		11/24 (45.8%)		0/4 (0%)		2/5 (40%)		0/6 (0%)		2/5 (40%)		4/6 (66.7%)		5/11 (45.5%)		2/5 (40%)		3/6 (50%)		2/6 (33.3%)		3/6 (50%)		3/5 (60%)		1/6 (16.7%)		9/20 (45%)		3/6 (50%)		6/12 (50%)		4/7 (57.1%)		5/6 (83.3%)		5/12 (41.7%)		2/6 (33.3%)		5/11 (45.5%)		4/6 (66.7%)		4/6 (66.7%)		13/20 (65%)		8/20 (40%)		14/19 (73.7%)		15/41 (36.6%)		9/21 (42.9%)		10/21 (47.6%)		7/22 (31.8%)		8/22 (36.4%)		5/19 (26.3%)		4/16 (25%)		4/14 (28.6%)		208/490 (42.4%)
Blood and lymphatic system disorders
Anaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Leukocytosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Thrombocytopenia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cardiac disorders
Atrial fibrillation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cardiac tamponade	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Coronary artery disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Sinus tachycardia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Ear and labyrinth disorders
Vertigo	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Endocrine disorders
Adrenal insufficiency	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypophysitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypothyroidism	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Eye disorders
Eyelid ptosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Visual impairment	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Gastrointestinal disorders
Abdominal distension	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Abdominal pain	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		2/11 (18.2%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		9/490 (1.8%)
Abdominal pain upper	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Ascites	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		7/490 (1.4%)
Colitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/20 (10%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Constipation	1/13 (7.7%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Diarrhoea	0/13 (0%)		1/12 (8.3%)		2/6 (33.3%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Diverticulum intestinal haemorrhagic	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Duodenal ulcer	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Dysphagia	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Gastrointestinal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Gastrooesophageal reflux disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Ileal ulcer	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Intra-abdominal fluid collection	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Large intestinal obstruction	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Lower gastrointestinal haemorrhage	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Melaena	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Nausea	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		7/490 (1.4%)
Obstruction gastric	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pancreatitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		1/490 (0.2%)
Pancreatitis acute	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Small intestinal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Small intestinal obstruction	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		2/5 (40%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Subileus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vomiting	1/13 (7.7%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		9/490 (1.8%)
General disorders
Asthenia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		3/490 (0.6%)
Fatigue	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
General physical health deterioration	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Malaise	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Multiple organ dysfunction syndrome	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Non-cardiac chest pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Peripheral swelling	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Pyrexia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		2/6 (33.3%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		13/490 (2.7%)
Systemic inflammatory response syndrome	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hepatobiliary disorders
Autoimmune hepatitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Bile duct stenosis	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cholangitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cholecystitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		2/490 (0.4%)
Hepatic failure	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hepatic haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hepatic pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hyperbilirubinaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Jaundice	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Liver injury	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Infections and infestations
Abscess	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Bacteraemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Bacterial infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Bronchiolitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Bronchitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cellulitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Clostridium difficile colitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Device related infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		3/490 (0.6%)
Escherichia bacteraemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Hepatitis E	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Herpes zoster	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Influenza	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Lower respiratory tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Osteomyelitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Parainfluenzae virus infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Pelvic infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pneumonia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		3/19 (15.8%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		7/490 (1.4%)
Pneumonia viral	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Post procedural infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Respiratory tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Rotavirus infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Sepsis	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Septic shock	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Soft tissue infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Urinary tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Wound infection	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Injury, poisoning and procedural complications
Clavicle fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Fall	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Femoral neck fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Gastroenteritis radiation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pelvic fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Post procedural haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Investigations
Amylase increased	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Aspartate aminotransferase increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Blood bilirubin increased	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Blood creatine phosphokinase increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Lipase increased	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Troponin I increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Urine output decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Metabolism and nutrition disorders
Adult failure to thrive	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cachexia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Decreased appetite	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Dehydration	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Diabetic ketoacidosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypercalcaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Hyperglycaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypoglycaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypokalaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hyponatraemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Metabolic acidosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Tumour lysis syndrome	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Back pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Bone lesion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Chest wall mass	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Groin pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Muscular weakness	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Neck pain	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pain in extremity	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		5/490 (1%)
Pain in jaw	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pathological fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Polyarthritis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cancer pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		2/6 (33.3%)		1/11 (9.1%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Malignant ascites	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Malignant pleural effusion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Metastases to bone	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Metastases to central nervous system	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Oncologic complication	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Synovial sarcoma	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Tumour pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Nervous system disorders
Brain oedema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cerebral haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cerebrovascular accident	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Dizziness	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Epilepsy	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Headache	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Myasthenia gravis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Nervous system disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Parkinson's disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Partial seizures	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Seizure	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Spinal cord compression	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Transient ischaemic attack	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Product Issues
Device occlusion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Psychiatric disorders
Confusional state	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Mental status changes	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Renal and urinary disorders
Acute kidney injury	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
Haematuria	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Renal colic	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Renal impairment	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Renal pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Urinary retention	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vaginal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cough	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Dyspnoea	1/13 (7.7%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		2/6 (33.3%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		3/21 (14.3%)		0/22 (0%)		0/22 (0%)		2/19 (10.5%)		2/16 (12.5%)		0/14 (0%)		20/490 (4.1%)
Dyspnoea exertional	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Haemoptysis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Hypoxia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Pleural effusion	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		2/21 (9.5%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		12/490 (2.4%)
Pneumonia aspiration	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pneumonitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Pneumothorax	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Pulmonary embolism	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Respiratory failure	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Skin and subcutaneous tissue disorders
Dermatitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Ecchymosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vascular disorders
Deep vein thrombosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypertension	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypotension	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Superior vena cava occlusion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vena cava thrombosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Other (Not Including Serious) Adverse Events
	Phase 1: LAG525 1 mg/kg Q2W		Phase 1: LAG525 3 mg/kg Q2W		Phase 1: LAG525 5 mg/kg Q2W		Phase 1: LAG525 10 mg/kg Q2W		Phase 1: LAG525 15 mg/kg Q2W		Phase 1: LAG525 240 mg Q2W		Phase 1: LAG525 400 mg Q2W		Phase 1: LAG525 1 mg/kg Q2W-JP		Phase 1: LAG525 240 mg Q2W-JP		Phase 1: LAG525 400 mg Q2W-JP		Phase 1: LAG525 3 mg/kg Q4W		Phase 1: LAG525 5 mg/kg Q4W		Phase 1: LAG525 10 mg/kg Q4W		Phase 1: LAG525 400 mg Q4W		Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W		Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W		Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W		Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W		Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W		Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W		Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W		Phase 2: Naive - NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Naive - TNBC - LAG525 600 mg Q4W + PDR001 400 mg Q4W		Phase 2: Pre-treated -NSCLC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Melanoma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - RCC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - Mesothelioma - LAG525 400 mg Q3W + PDR001 300 mg Q3W		Phase 2: Pre-treated - TNBC - LAG525 400 mg Q3W + PDR001 300 mg Q3W		All Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	13/13 (100%)		11/12 (91.7%)		6/6 (100%)		6/6 (100%)		6/6 (100%)		24/25 (96%)		24/24 (100%)		4/4 (100%)		5/5 (100%)		6/6 (100%)		5/5 (100%)		6/6 (100%)		11/11 (100%)		5/5 (100%)		6/6 (100%)		6/6 (100%)		6/6 (100%)		5/5 (100%)		6/6 (100%)		19/20 (95%)		5/6 (83.3%)		12/12 (100%)		7/7 (100%)		6/6 (100%)		12/12 (100%)		6/6 (100%)		11/11 (100%)		6/6 (100%)		6/6 (100%)		19/20 (95%)		17/20 (85%)		19/19 (100%)		41/41 (100%)		21/21 (100%)		21/21 (100%)		21/22 (95.5%)		22/22 (100%)		19/19 (100%)		16/16 (100%)		14/14 (100%)		481/490 (98.2%)
Blood and lymphatic system disorders
Anaemia	3/13 (23.1%)		3/12 (25%)		2/6 (33.3%)		2/6 (33.3%)		2/6 (33.3%)		3/25 (12%)		6/24 (25%)		2/4 (50%)		3/5 (60%)		0/6 (0%)		1/5 (20%)		3/6 (50%)		3/11 (27.3%)		0/5 (0%)		2/6 (33.3%)		1/6 (16.7%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		5/20 (25%)		1/6 (16.7%)		2/12 (16.7%)		2/7 (28.6%)		2/6 (33.3%)		2/12 (16.7%)		1/6 (16.7%)		4/11 (36.4%)		1/6 (16.7%)		1/6 (16.7%)		2/20 (10%)		2/20 (10%)		9/19 (47.4%)		3/41 (7.3%)		2/21 (9.5%)		3/21 (14.3%)		1/22 (4.5%)		6/22 (27.3%)		4/19 (21.1%)		1/16 (6.3%)		0/14 (0%)		92/490 (18.8%)
Disseminated intravascular coagulation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Iron deficiency anaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		3/490 (0.6%)
Leukocytosis	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Leukopenia	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Lymphadenopathy	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Lymphopenia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Neutropenia	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		8/490 (1.6%)
Thrombocytopenia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		2/14 (14.3%)		11/490 (2.2%)
Thrombocytosis	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cardiac disorders
Aortic valve disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Atrial flutter	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Atrial tachycardia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Atrioventricular block first degree	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Palpitations	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Pericardial effusion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		2/22 (9.1%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		5/490 (1%)
Sinus bradycardia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Sinus tachycardia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		8/490 (1.6%)
Tachycardia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Ventricular arrhythmia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Ventricular tachycardia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Ear and labyrinth disorders
Ear congestion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Ear pain	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		4/490 (0.8%)
External ear disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypoacusis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Otorrhoea	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vertigo	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Endocrine disorders
Adrenal insufficiency	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Hyperthyroidism	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		0/19 (0%)		3/41 (7.3%)		2/21 (9.5%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		16/490 (3.3%)
Hypophysitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypothyroidism	0/13 (0%)		2/12 (16.7%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		2/6 (33.3%)		2/6 (33.3%)		0/5 (0%)		2/6 (33.3%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		2/20 (10%)		1/20 (5%)		4/19 (21.1%)		5/41 (12.2%)		1/21 (4.8%)		1/21 (4.8%)		0/22 (0%)		1/22 (4.5%)		1/19 (5.3%)		1/16 (6.3%)		1/14 (7.1%)		36/490 (7.3%)
Eye disorders
Blepharitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Blindness unilateral	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Conjunctival haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Diplopia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Dry eye	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		4/490 (0.8%)
Erythema of eyelid	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Eye oedema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Eye pruritus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Eye swelling	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Eyelid ptosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Keratitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Lacrimal disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Lacrimation increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Periorbital swelling	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Swelling of eyelid	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vision blurred	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		0/19 (0%)		1/41 (2.4%)		2/21 (9.5%)		0/21 (0%)		0/22 (0%)		2/22 (9.1%)		0/19 (0%)		2/16 (12.5%)		1/14 (7.1%)		14/490 (2.9%)
Visual acuity reduced	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vitreous floaters	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Gastrointestinal disorders
Abdominal discomfort	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Abdominal distension	0/13 (0%)		4/12 (33.3%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		2/25 (8%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		3/11 (27.3%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		1/20 (5%)		4/20 (20%)		1/19 (5.3%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		27/490 (5.5%)
Abdominal hernia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Abdominal pain	1/13 (7.7%)		2/12 (16.7%)		2/6 (33.3%)		1/6 (16.7%)		1/6 (16.7%)		3/25 (12%)		6/24 (25%)		1/4 (25%)		2/5 (40%)		0/6 (0%)		2/5 (40%)		1/6 (16.7%)		2/11 (18.2%)		2/5 (40%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/5 (20%)		1/6 (16.7%)		5/20 (25%)		0/6 (0%)		1/12 (8.3%)		1/7 (14.3%)		2/6 (33.3%)		2/12 (16.7%)		3/6 (50%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		3/19 (15.8%)		3/41 (7.3%)		1/21 (4.8%)		1/21 (4.8%)		2/22 (9.1%)		6/22 (27.3%)		2/19 (10.5%)		3/16 (18.8%)		1/14 (7.1%)		68/490 (13.9%)
Abdominal pain lower	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		1/14 (7.1%)		6/490 (1.2%)
Abdominal pain upper	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		2/6 (33.3%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		3/41 (7.3%)		0/21 (0%)		0/21 (0%)		2/22 (9.1%)		1/22 (4.5%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		24/490 (4.9%)
Anal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Anal incontinence	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Anal pruritus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Aphthous ulcer	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Aptyalism	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Ascites	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		2/20 (10%)		2/19 (10.5%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		13/490 (2.7%)
Colitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Constipation	3/13 (23.1%)		2/12 (16.7%)		2/6 (33.3%)		0/6 (0%)		4/6 (66.7%)		3/25 (12%)		6/24 (25%)		1/4 (25%)		1/5 (20%)		2/6 (33.3%)		1/5 (20%)		1/6 (16.7%)		4/11 (36.4%)		1/5 (20%)		2/6 (33.3%)		0/6 (0%)		2/6 (33.3%)		2/5 (40%)		0/6 (0%)		7/20 (35%)		0/6 (0%)		2/12 (16.7%)		1/7 (14.3%)		3/6 (50%)		3/12 (25%)		2/6 (33.3%)		3/11 (27.3%)		0/6 (0%)		1/6 (16.7%)		10/20 (50%)		4/20 (20%)		4/19 (21.1%)		7/41 (17.1%)		2/21 (9.5%)		4/21 (19%)		3/22 (13.6%)		4/22 (18.2%)		5/19 (26.3%)		0/16 (0%)		0/14 (0%)		102/490 (20.8%)
Dental caries	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Diarrhoea	1/13 (7.7%)		1/12 (8.3%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		5/25 (20%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/5 (20%)		3/6 (50%)		10/20 (50%)		2/6 (33.3%)		3/12 (25%)		0/7 (0%)		1/6 (16.7%)		6/12 (50%)		2/6 (33.3%)		3/11 (27.3%)		0/6 (0%)		4/6 (66.7%)		5/20 (25%)		4/20 (20%)		4/19 (21.1%)		8/41 (19.5%)		3/21 (14.3%)		2/21 (9.5%)		5/22 (22.7%)		4/22 (18.2%)		1/19 (5.3%)		4/16 (25%)		2/14 (14.3%)		91/490 (18.6%)
Dry mouth	0/13 (0%)		2/12 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		1/24 (4.2%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		3/11 (27.3%)		0/6 (0%)		2/6 (33.3%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		3/41 (7.3%)		1/21 (4.8%)		1/21 (4.8%)		2/22 (9.1%)		1/22 (4.5%)		0/19 (0%)		1/16 (6.3%)		1/14 (7.1%)		28/490 (5.7%)
Duodenal ulcer	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Dyspepsia	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		3/19 (15.8%)		1/16 (6.3%)		1/14 (7.1%)		16/490 (3.3%)
Dysphagia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/20 (10%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		11/490 (2.2%)
Epigastric discomfort	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		1/490 (0.2%)
Flatulence	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Gastric ulcer	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Gastrointestinal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Gastrooesophageal reflux disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		3/20 (15%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		4/12 (33.3%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		3/41 (7.3%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		25/490 (5.1%)
Gingival bleeding	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Glossitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Haematochezia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Haemorrhoids	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		7/490 (1.4%)
Hypoaesthesia oral	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Inguinal hernia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Intra-abdominal fluid collection	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Large intestinal obstruction	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Melaena	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Mouth ulceration	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Nausea	1/13 (7.7%)		3/12 (25%)		1/6 (16.7%)		2/6 (33.3%)		1/6 (16.7%)		8/25 (32%)		7/24 (29.2%)		0/4 (0%)		2/5 (40%)		2/6 (33.3%)		0/5 (0%)		2/6 (33.3%)		3/11 (27.3%)		1/5 (20%)		1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		2/5 (40%)		0/6 (0%)		9/20 (45%)		2/6 (33.3%)		4/12 (33.3%)		3/7 (42.9%)		0/6 (0%)		7/12 (58.3%)		1/6 (16.7%)		5/11 (45.5%)		2/6 (33.3%)		3/6 (50%)		2/20 (10%)		6/20 (30%)		5/19 (26.3%)		12/41 (29.3%)		3/21 (14.3%)		5/21 (23.8%)		7/22 (31.8%)		9/22 (40.9%)		3/19 (15.8%)		6/16 (37.5%)		1/14 (7.1%)		134/490 (27.3%)
Odynophagia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Oesophagitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Oral pain	1/13 (7.7%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Pancreatitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Rectal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Rectal tenesmus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Small intestinal obstruction	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Stomatitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		4/20 (20%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		2/12 (16.7%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		1/21 (4.8%)		1/22 (4.5%)		1/22 (4.5%)		1/19 (5.3%)		2/16 (12.5%)		1/14 (7.1%)		22/490 (4.5%)
Tongue discomfort	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Toothache	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/11 (18.2%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Upper gastrointestinal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Vomiting	1/13 (7.7%)		2/12 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		5/25 (20%)		5/24 (20.8%)		0/4 (0%)		2/5 (40%)		1/6 (16.7%)		1/5 (20%)		1/6 (16.7%)		2/11 (18.2%)		0/5 (0%)		2/6 (33.3%)		0/6 (0%)		1/6 (16.7%)		2/5 (40%)		1/6 (16.7%)		3/20 (15%)		2/6 (33.3%)		4/12 (33.3%)		1/7 (14.3%)		0/6 (0%)		4/12 (33.3%)		0/6 (0%)		4/11 (36.4%)		1/6 (16.7%)		2/6 (33.3%)		2/20 (10%)		1/20 (5%)		5/19 (26.3%)		5/41 (12.2%)		3/21 (14.3%)		5/21 (23.8%)		6/22 (27.3%)		4/22 (18.2%)		2/19 (10.5%)		1/16 (6.3%)		1/14 (7.1%)		85/490 (17.3%)
General disorders
Asthenia	0/13 (0%)		1/12 (8.3%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		6/24 (25%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		2/5 (40%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/5 (20%)		1/6 (16.7%)		4/20 (20%)		1/6 (16.7%)		1/12 (8.3%)		2/7 (28.6%)		1/6 (16.7%)		2/12 (16.7%)		0/6 (0%)		3/11 (27.3%)		1/6 (16.7%)		3/6 (50%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		9/41 (22%)		1/21 (4.8%)		3/21 (14.3%)		5/22 (22.7%)		3/22 (13.6%)		3/19 (15.8%)		1/16 (6.3%)		2/14 (14.3%)		63/490 (12.9%)
Axillary pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Catheter site erythema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Catheter site pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Chest discomfort	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		6/490 (1.2%)
Chills	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		1/12 (8.3%)		1/6 (16.7%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		10/490 (2%)
Early satiety	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Extravasation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Face oedema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Facial pain	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Fatigue	1/13 (7.7%)		3/12 (25%)		2/6 (33.3%)		2/6 (33.3%)		3/6 (50%)		7/25 (28%)		8/24 (33.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		3/5 (60%)		1/6 (16.7%)		4/11 (36.4%)		0/5 (0%)		2/6 (33.3%)		2/6 (33.3%)		2/6 (33.3%)		3/5 (60%)		2/6 (33.3%)		10/20 (50%)		1/6 (16.7%)		5/12 (41.7%)		1/7 (14.3%)		2/6 (33.3%)		2/12 (16.7%)		2/6 (33.3%)		2/11 (18.2%)		2/6 (33.3%)		2/6 (33.3%)		4/20 (20%)		4/20 (20%)		3/19 (15.8%)		9/41 (22%)		4/21 (19%)		6/21 (28.6%)		2/22 (9.1%)		4/22 (18.2%)		6/19 (31.6%)		8/16 (50%)		3/14 (21.4%)		127/490 (25.9%)
Gait disturbance	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Inflammation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Influenza like illness	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		2/41 (4.9%)		1/21 (4.8%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		9/490 (1.8%)
Injection site reaction	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Localised oedema	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Malaise	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		9/490 (1.8%)
Mucosal disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Mucosal dryness	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Mucosal inflammation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Nodule	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Non-cardiac chest pain	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		3/11 (27.3%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		1/7 (14.3%)		0/6 (0%)		3/12 (25%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		1/19 (5.3%)		6/41 (14.6%)		1/21 (4.8%)		1/21 (4.8%)		1/22 (4.5%)		1/22 (4.5%)		0/19 (0%)		1/16 (6.3%)		1/14 (7.1%)		29/490 (5.9%)
Oedema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Oedema peripheral	1/13 (7.7%)		1/12 (8.3%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		1/4 (25%)		1/5 (20%)		1/6 (16.7%)		1/5 (20%)		1/6 (16.7%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		3/6 (50%)		2/20 (10%)		1/6 (16.7%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		3/12 (25%)		0/6 (0%)		3/11 (27.3%)		3/6 (50%)		2/6 (33.3%)		1/20 (5%)		3/20 (15%)		4/19 (21.1%)		2/41 (4.9%)		0/21 (0%)		2/21 (9.5%)		2/22 (9.1%)		1/22 (4.5%)		1/19 (5.3%)		2/16 (12.5%)		0/14 (0%)		47/490 (9.6%)
Pain	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		2/20 (10%)		0/6 (0%)		2/12 (16.7%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		3/41 (7.3%)		2/21 (9.5%)		4/21 (19%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		23/490 (4.7%)
Peripheral swelling	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		2/6 (33.3%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		11/490 (2.2%)
Pyrexia	3/13 (23.1%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		7/25 (28%)		5/24 (20.8%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		2/11 (18.2%)		2/5 (40%)		1/6 (16.7%)		0/6 (0%)		2/6 (33.3%)		2/5 (40%)		1/6 (16.7%)		2/20 (10%)		3/6 (50%)		1/12 (8.3%)		0/7 (0%)		3/6 (50%)		2/12 (16.7%)		1/6 (16.7%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		4/20 (20%)		3/20 (15%)		4/19 (21.1%)		7/41 (17.1%)		5/21 (23.8%)		5/21 (23.8%)		4/22 (18.2%)		2/22 (9.1%)		5/19 (26.3%)		2/16 (12.5%)		1/14 (7.1%)		85/490 (17.3%)
Secretion discharge	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Suprapubic pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Xerosis	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hepatobiliary disorders
Bile duct stenosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cholecystitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Cholelithiasis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hepatic pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hepatic vein thrombosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hyperbilirubinaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/20 (10%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Hypertransaminasaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		2/490 (0.4%)
Jaundice	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		3/490 (0.6%)
Ocular icterus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Immune system disorders
Contrast media allergy	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Infections and infestations
Abscess limb	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Bronchitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Candida infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		2/11 (18.2%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Cellulitis	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Clostridium difficile colitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Clostridium difficile infection	1/13 (7.7%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Conjunctivitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Device related infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		1/490 (0.2%)
Ear infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		2/22 (9.1%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Erythema migrans	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Escherichia urinary tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Gingivitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hepatitis B	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Herpes dermatitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Herpes zoster	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Hordeolum	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Influenza	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		1/19 (5.3%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		14/490 (2.9%)
Infusion site infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Lower respiratory tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Mucosal infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Nasopharyngitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		8/490 (1.6%)
Oral candidiasis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
Oral herpes	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Otitis media	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Paronychia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Pharyngitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Pneumonia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		2/6 (33.3%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		0/19 (0%)		3/41 (7.3%)		0/21 (0%)		0/21 (0%)		2/22 (9.1%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		16/490 (3.3%)
Pneumonia bacterial	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Post procedural infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Respiratory tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Respiratory tract infection viral	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Rhinitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		4/490 (0.8%)
Sepsis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Sialoadenitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Sinusitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Skin infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Tinea infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Tinea versicolour	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Tooth abscess	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		2/12 (16.7%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Upper respiratory tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		2/25 (8%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		3/20 (15%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		2/12 (16.7%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		1/19 (5.3%)		6/41 (14.6%)		0/21 (0%)		0/21 (0%)		3/22 (13.6%)		2/22 (9.1%)		0/19 (0%)		1/16 (6.3%)		1/14 (7.1%)		25/490 (5.1%)
Urinary tract infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		1/5 (20%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/20 (10%)		1/6 (16.7%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		2/22 (9.1%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		18/490 (3.7%)
Viral infection	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Viral upper respiratory tract infection	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Wound infection	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Injury, poisoning and procedural complications
Contusion	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Eye contusion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hand fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Head injury	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Ligament sprain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Limb injury	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Lumbar vertebral fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Poisoning	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Post procedural inflammation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Postoperative wound complication	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Procedural nausea	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Procedural pain	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		9/490 (1.8%)
Spinal compression fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Sunburn	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Wound haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Investigations
Alanine aminotransferase increased	1/13 (7.7%)		2/12 (16.7%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		2/25 (8%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		3/6 (50%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		3/20 (15%)		0/6 (0%)		2/12 (16.7%)		0/7 (0%)		0/6 (0%)		2/12 (16.7%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		2/20 (10%)		1/20 (5%)		2/19 (10.5%)		1/41 (2.4%)		1/21 (4.8%)		1/21 (4.8%)		1/22 (4.5%)		1/22 (4.5%)		2/19 (10.5%)		0/16 (0%)		2/14 (14.3%)		34/490 (6.9%)
Amylase increased	2/13 (15.4%)		1/12 (8.3%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		2/20 (10%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		2/6 (33.3%)		0/12 (0%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		3/41 (7.3%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		2/19 (10.5%)		0/16 (0%)		1/14 (7.1%)		24/490 (4.9%)
Aspartate aminotransferase increased	1/13 (7.7%)		2/12 (16.7%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		2/25 (8%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		3/6 (50%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		3/20 (15%)		0/6 (0%)		3/12 (25%)		0/7 (0%)		0/6 (0%)		2/12 (16.7%)		2/6 (33.3%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		3/20 (15%)		2/20 (10%)		2/19 (10.5%)		2/41 (4.9%)		1/21 (4.8%)		2/21 (9.5%)		0/22 (0%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		1/14 (7.1%)		40/490 (8.2%)
Blood albumin decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Blood alkaline phosphatase increased	2/13 (15.4%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		4/25 (16%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		2/20 (10%)		0/6 (0%)		2/12 (16.7%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		1/6 (16.7%)		2/11 (18.2%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		2/20 (10%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		29/490 (5.9%)
Blood bilirubin increased	0/13 (0%)		1/12 (8.3%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		3/25 (12%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		2/6 (33.3%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		17/490 (3.5%)
Blood calcium	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Blood creatine phosphokinase increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Blood creatinine increased	0/13 (0%)		2/12 (16.7%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/11 (18.2%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/20 (5%)		1/20 (5%)		3/19 (15.8%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		1/14 (7.1%)		26/490 (5.3%)
Blood glucose increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Blood potassium increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Blood prolactin abnormal	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Blood sodium decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Blood thyroid stimulating hormone abnormal	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Blood thyroid stimulating hormone increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Blood urea increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Blood uric acid increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		2/22 (9.1%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
C-reactive protein increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Computerised tomogram abnormal	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Electrocardiogram QT prolonged	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		2/490 (0.4%)
Gamma-glutamyltransferase increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		2/12 (16.7%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		7/490 (1.4%)
Glomerular filtration rate decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Haemoglobin decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Hepatitis C virus test positive	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Lipase increased	2/13 (15.4%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		3/24 (12.5%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		3/41 (7.3%)		1/21 (4.8%)		0/21 (0%)		2/22 (9.1%)		0/22 (0%)		1/19 (5.3%)		2/16 (12.5%)		2/14 (14.3%)		27/490 (5.5%)
Lymphocyte count decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		2/41 (4.9%)		2/21 (9.5%)		1/21 (4.8%)		0/22 (0%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		1/14 (7.1%)		13/490 (2.7%)
Lymphocyte count increased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		1/490 (0.2%)
Neutrophil count decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		2/5 (40%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Platelet count decreased	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		1/4 (25%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		7/490 (1.4%)
Protein urine	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Thyroxine free abnormal	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Transaminases increased	0/13 (0%)		2/12 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Urine output decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Weight decreased	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		2/6 (33.3%)		1/6 (16.7%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		5/20 (25%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		1/20 (5%)		4/19 (21.1%)		3/41 (7.3%)		0/21 (0%)		1/21 (4.8%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		30/490 (6.1%)
Weight increased	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
White blood cell count	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
White blood cell count decreased	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		1/4 (25%)		3/5 (60%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		0/41 (0%)		2/21 (9.5%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		9/490 (1.8%)
Metabolism and nutrition disorders
Cachexia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Decreased appetite	3/13 (23.1%)		3/12 (25%)		2/6 (33.3%)		0/6 (0%)		2/6 (33.3%)		6/25 (24%)		6/24 (25%)		0/4 (0%)		3/5 (60%)		2/6 (33.3%)		1/5 (20%)		0/6 (0%)		1/11 (9.1%)		3/5 (60%)		3/6 (50%)		0/6 (0%)		0/6 (0%)		2/5 (40%)		0/6 (0%)		9/20 (45%)		0/6 (0%)		6/12 (50%)		1/7 (14.3%)		3/6 (50%)		3/12 (25%)		2/6 (33.3%)		3/11 (27.3%)		2/6 (33.3%)		2/6 (33.3%)		4/20 (20%)		2/20 (10%)		4/19 (21.1%)		11/41 (26.8%)		4/21 (19%)		2/21 (9.5%)		6/22 (27.3%)		5/22 (22.7%)		3/19 (15.8%)		3/16 (18.8%)		1/14 (7.1%)		113/490 (23.1%)
Dehydration	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		2/12 (16.7%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		1/6 (16.7%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		13/490 (2.7%)
Diabetes mellitus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Gout	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hyperamylasaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypercalcaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		2/12 (16.7%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		3/19 (15.8%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		3/19 (15.8%)		0/16 (0%)		2/14 (14.3%)		17/490 (3.5%)
Hyperglycaemia	0/13 (0%)		3/12 (25%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		1/7 (14.3%)		1/6 (16.7%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		2/22 (9.1%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		18/490 (3.7%)
Hyperkalaemia	0/13 (0%)		2/12 (16.7%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		2/11 (18.2%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		2/19 (10.5%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		4/19 (21.1%)		2/16 (12.5%)		3/14 (21.4%)		22/490 (4.5%)
Hypermagnesaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hypernatraemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		3/490 (0.6%)
Hyperphosphataemia	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		2/19 (10.5%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Hypertriglyceridaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hyperuricaemia	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Hypoalbuminaemia	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		2/12 (16.7%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		22/490 (4.5%)
Hypocalcaemia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		2/21 (9.5%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		9/490 (1.8%)
Hypokalaemia	3/13 (23.1%)		1/12 (8.3%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		2/6 (33.3%)		3/20 (15%)		0/6 (0%)		3/12 (25%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		25/490 (5.1%)
Hypomagnesaemia	1/13 (7.7%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		2/21 (9.5%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		1/14 (7.1%)		23/490 (4.7%)
Hyponatraemia	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		3/6 (50%)		2/25 (8%)		3/24 (12.5%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/5 (40%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		1/6 (16.7%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		5/20 (25%)		0/20 (0%)		2/19 (10.5%)		3/41 (7.3%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		2/19 (10.5%)		1/16 (6.3%)		0/14 (0%)		31/490 (6.3%)
Hypophosphataemia	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		4/24 (16.7%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/11 (18.2%)		0/5 (0%)		1/6 (16.7%)		2/6 (33.3%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		4/41 (9.8%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		2/22 (9.1%)		0/19 (0%)		1/16 (6.3%)		1/14 (7.1%)		28/490 (5.7%)
Iron deficiency	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		1/490 (0.2%)
Malnutrition	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vitamin B1 deficiency	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/13 (23.1%)		1/12 (8.3%)		1/6 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		4/25 (16%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		2/11 (18.2%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		2/6 (33.3%)		4/20 (20%)		1/6 (16.7%)		2/12 (16.7%)		1/7 (14.3%)		0/6 (0%)		4/12 (33.3%)		2/6 (33.3%)		2/11 (18.2%)		1/6 (16.7%)		1/6 (16.7%)		7/20 (35%)		4/20 (20%)		5/19 (26.3%)		8/41 (19.5%)		6/21 (28.6%)		3/21 (14.3%)		4/22 (18.2%)		7/22 (31.8%)		1/19 (5.3%)		4/16 (25%)		1/14 (7.1%)		88/490 (18%)
Arthritis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Autoimmune arthritis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Back pain	1/13 (7.7%)		1/12 (8.3%)		1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		2/25 (8%)		4/24 (16.7%)		0/4 (0%)		4/5 (80%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		2/11 (18.2%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		3/20 (15%)		1/6 (16.7%)		2/12 (16.7%)		0/7 (0%)		0/6 (0%)		3/12 (25%)		2/6 (33.3%)		4/11 (36.4%)		2/6 (33.3%)		0/6 (0%)		3/20 (15%)		1/20 (5%)		3/19 (15.8%)		6/41 (14.6%)		1/21 (4.8%)		2/21 (9.5%)		4/22 (18.2%)		5/22 (22.7%)		1/19 (5.3%)		3/16 (18.8%)		1/14 (7.1%)		69/490 (14.1%)
Bone pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		2/22 (9.1%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		13/490 (2.7%)
Flank pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		10/490 (2%)
Groin pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		2/22 (9.1%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		9/490 (1.8%)
Intervertebral disc displacement	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Joint stiffness	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Joint swelling	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Muscle spasms	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		3/41 (7.3%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		1/14 (7.1%)		11/490 (2.2%)
Muscular weakness	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		2/11 (18.2%)		0/5 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		2/12 (16.7%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		14/490 (2.9%)
Musculoskeletal chest pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		4/41 (9.8%)		0/21 (0%)		0/21 (0%)		2/22 (9.1%)		1/22 (4.5%)		2/19 (10.5%)		0/16 (0%)		0/14 (0%)		20/490 (4.1%)
Musculoskeletal pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Musculoskeletal stiffness	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Myalgia	0/13 (0%)		2/12 (16.7%)		0/6 (0%)		0/6 (0%)		2/6 (33.3%)		1/25 (4%)		4/24 (16.7%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		2/6 (33.3%)		2/20 (10%)		0/6 (0%)		2/12 (16.7%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		3/11 (27.3%)		0/6 (0%)		2/6 (33.3%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		3/21 (14.3%)		0/21 (0%)		3/22 (13.6%)		0/22 (0%)		1/19 (5.3%)		2/16 (12.5%)		1/14 (7.1%)		36/490 (7.3%)
Neck pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		11/490 (2.2%)
Pain in extremity	1/13 (7.7%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		3/25 (12%)		1/24 (4.2%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		2/6 (33.3%)		0/12 (0%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		2/20 (10%)		0/19 (0%)		4/41 (9.8%)		1/21 (4.8%)		2/21 (9.5%)		2/22 (9.1%)		2/22 (9.1%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		34/490 (6.9%)
Pain in jaw	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		6/490 (1.2%)
Pathological fracture	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Polyarthritis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Tendonitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
Tumour associated fever	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		2/21 (9.5%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Tumour haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Tumour pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/25 (8%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		4/41 (9.8%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		3/16 (18.8%)		1/14 (7.1%)		11/490 (2.2%)
Nervous system disorders
Amnesia	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Ataxia	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Brain oedema	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Clonus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Cognitive disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Dizziness	1/13 (7.7%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		2/6 (33.3%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		1/7 (14.3%)		1/6 (16.7%)		1/12 (8.3%)		1/6 (16.7%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		3/20 (15%)		1/20 (5%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		4/21 (19%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		28/490 (5.7%)
Dysgeusia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		2/12 (16.7%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		4/41 (9.8%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		15/490 (3.1%)
Dyskinesia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Essential tremor	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Facial paralysis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Headache	1/13 (7.7%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		3/25 (12%)		5/24 (20.8%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		2/6 (33.3%)		1/5 (20%)		1/6 (16.7%)		2/20 (10%)		1/6 (16.7%)		0/12 (0%)		2/7 (28.6%)		1/6 (16.7%)		2/12 (16.7%)		1/6 (16.7%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		2/20 (10%)		1/20 (5%)		0/19 (0%)		3/41 (7.3%)		2/21 (9.5%)		2/21 (9.5%)		2/22 (9.1%)		6/22 (27.3%)		5/19 (26.3%)		3/16 (18.8%)		2/14 (14.3%)		56/490 (11.4%)
Hemiparesis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Hypoaesthesia	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Lethargy	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		2/6 (33.3%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Memory impairment	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Neuralgia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Neuropathy peripheral	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		7/490 (1.4%)
Paraesthesia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		3/20 (15%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		2/22 (9.1%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		14/490 (2.9%)
Peripheral sensory neuropathy	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Polyneuropathy	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Presyncope	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Sciatica	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		0/41 (0%)		2/21 (9.5%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Seizure	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		2/490 (0.4%)
Somnolence	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		2/6 (33.3%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		3/19 (15.8%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
Spinal cord compression	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Syncope	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Tremor	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		6/490 (1.2%)
Trigeminal nerve disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Psychiatric disorders
Anxiety	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		2/6 (33.3%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		1/6 (16.7%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		3/41 (7.3%)		0/21 (0%)		1/21 (4.8%)		2/22 (9.1%)		0/22 (0%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		21/490 (4.3%)
Confusional state	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Depression	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		7/490 (1.4%)
Hallucination	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hallucination, visual	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Insomnia	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		6/24 (25%)		2/4 (50%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		2/12 (16.7%)		1/6 (16.7%)		1/11 (9.1%)		1/6 (16.7%)		1/6 (16.7%)		0/20 (0%)		1/20 (5%)		2/19 (10.5%)		3/41 (7.3%)		2/21 (9.5%)		1/21 (4.8%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		2/16 (12.5%)		2/14 (14.3%)		36/490 (7.3%)
Irritability	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Personality change	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Sleep disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Renal and urinary disorders
Acute kidney injury	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		10/490 (2%)
Bladder disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Chronic kidney disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Dysuria	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		1/4 (25%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		3/41 (7.3%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
Haematuria	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		1/6 (16.7%)		1/12 (8.3%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		10/490 (2%)
Hydronephrosis	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		2/490 (0.4%)
Micturition urgency	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Nocturia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Oliguria	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		2/490 (0.4%)
Pollakiuria	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Proteinuria	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Renal failure	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Renal impairment	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Renal pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Urinary incontinence	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Urinary retention	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Urinary tract obstruction	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Reproductive system and breast disorders
Adnexa uteri pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Benign prostatic hyperplasia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Breast haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Breast pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		3/21 (14.3%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Erectile dysfunction	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Genital swelling	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Gynaecomastia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Metrorrhagia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Oedema genital	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Pelvic pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		2/6 (33.3%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		2/21 (9.5%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		5/490 (1%)
Penile erythema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Penile oedema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Scrotal oedema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Testicular pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vaginal discharge	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Vaginal haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Vulvovaginal pain	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vulvovaginal pruritus	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Respiratory, thoracic and mediastinal disorders
Aphonia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Bronchial obstruction	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Catarrh	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		3/41 (7.3%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
Cough	2/13 (15.4%)		1/12 (8.3%)		1/6 (16.7%)		0/6 (0%)		2/6 (33.3%)		3/25 (12%)		5/24 (20.8%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		4/11 (36.4%)		2/5 (40%)		4/6 (66.7%)		1/6 (16.7%)		1/6 (16.7%)		1/5 (20%)		3/6 (50%)		3/20 (15%)		1/6 (16.7%)		2/12 (16.7%)		0/7 (0%)		3/6 (50%)		3/12 (25%)		1/6 (16.7%)		3/11 (27.3%)		1/6 (16.7%)		0/6 (0%)		3/20 (15%)		3/20 (15%)		5/19 (26.3%)		11/41 (26.8%)		3/21 (14.3%)		4/21 (19%)		3/22 (13.6%)		3/22 (13.6%)		5/19 (26.3%)		3/16 (18.8%)		3/14 (21.4%)		94/490 (19.2%)
Dysphonia	2/13 (15.4%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		2/19 (10.5%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		2/22 (9.1%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		11/490 (2.2%)
Dyspnoea	3/13 (23.1%)		0/12 (0%)		2/6 (33.3%)		1/6 (16.7%)		2/6 (33.3%)		4/25 (16%)		7/24 (29.2%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		1/5 (20%)		1/6 (16.7%)		3/11 (27.3%)		1/5 (20%)		2/6 (33.3%)		1/6 (16.7%)		3/6 (50%)		1/5 (20%)		1/6 (16.7%)		6/20 (30%)		1/6 (16.7%)		1/12 (8.3%)		0/7 (0%)		2/6 (33.3%)		1/12 (8.3%)		1/6 (16.7%)		4/11 (36.4%)		1/6 (16.7%)		0/6 (0%)		4/20 (20%)		3/20 (15%)		5/19 (26.3%)		7/41 (17.1%)		2/21 (9.5%)		5/21 (23.8%)		3/22 (13.6%)		2/22 (9.1%)		2/19 (10.5%)		8/16 (50%)		3/14 (21.4%)		95/490 (19.4%)
Dyspnoea exertional	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		1/19 (5.3%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		14/490 (2.9%)
Epistaxis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Haemoptysis	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		1/6 (16.7%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		1/21 (4.8%)		3/22 (13.6%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		17/490 (3.5%)
Hiccups	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Hypoxia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		5/490 (1%)
Interstitial lung disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		3/490 (0.6%)
Nasal congestion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		2/25 (8%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		10/490 (2%)
Nasal dryness	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Nasal polyps	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Oropharyngeal pain	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		1/5 (20%)		2/6 (33.3%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		2/21 (9.5%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		1/14 (7.1%)		16/490 (3.3%)
Pleural effusion	0/13 (0%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		3/20 (15%)		2/20 (10%)		2/19 (10.5%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		16/490 (3.3%)
Pleuritic pain	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		3/490 (0.6%)
Pneumonitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Pneumothorax	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Productive cough	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/25 (0%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		4/20 (20%)		0/20 (0%)		1/19 (5.3%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		5/22 (22.7%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		20/490 (4.1%)
Pulmonary embolism	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Respiratory depression	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Rhinitis allergic	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Rhinorrhoea	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		2/20 (10%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		2/21 (9.5%)		1/22 (4.5%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		12/490 (2.4%)
Sinus congestion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		2/6 (33.3%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Sneezing	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Tachypnoea	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Tonsillar disorder	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Upper respiratory tract congestion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Upper-airway cough syndrome	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		1/16 (6.3%)		0/14 (0%)		5/490 (1%)
Wheezing	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Skin and subcutaneous tissue disorders
Alopecia	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		1/5 (20%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Dermatitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Dermatitis acneiform	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Dermatitis contact	0/13 (0%)		0/12 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Dry skin	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/25 (4%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		2/6 (33.3%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		1/6 (16.7%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		2/6 (33.3%)		3/20 (15%)		1/20 (5%)		1/19 (5.3%)		2/41 (4.9%)		1/21 (4.8%)		0/21 (0%)		2/22 (9.1%)		1/22 (4.5%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		24/490 (4.9%)
Ecchymosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		2/490 (0.4%)
Eczema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		1/20 (5%)		1/19 (5.3%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		5/490 (1%)
Erythema	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		2/20 (10%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		9/490 (1.8%)
Haemorrhage subcutaneous	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Hyperhidrosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		1/6 (16.7%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		4/490 (0.8%)
Nail disorder	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Nail toxicity	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		1/490 (0.2%)
Night sweats	2/13 (15.4%)		0/12 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		7/490 (1.4%)
Onychoclasis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Papule	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		2/490 (0.4%)
Pruritus	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/25 (4%)		2/24 (8.3%)		0/4 (0%)		1/5 (20%)		1/6 (16.7%)		0/5 (0%)		1/6 (16.7%)		1/11 (9.1%)		1/5 (20%)		1/6 (16.7%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		3/20 (15%)		1/6 (16.7%)		0/12 (0%)		1/7 (14.3%)		0/6 (0%)		1/12 (8.3%)		1/6 (16.7%)		2/11 (18.2%)		0/6 (0%)		1/6 (16.7%)		4/20 (20%)		2/20 (10%)		3/19 (15.8%)		8/41 (19.5%)		7/21 (33.3%)		5/21 (23.8%)		1/22 (4.5%)		3/22 (13.6%)		1/19 (5.3%)		4/16 (25%)		3/14 (21.4%)		64/490 (13.1%)
Rash	2/13 (15.4%)		0/12 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		0/25 (0%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		1/6 (16.7%)		5/20 (25%)		1/6 (16.7%)		1/12 (8.3%)		1/7 (14.3%)		0/6 (0%)		2/12 (16.7%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		5/20 (25%)		5/20 (25%)		7/19 (36.8%)		2/41 (4.9%)		1/21 (4.8%)		1/21 (4.8%)		4/22 (18.2%)		5/22 (22.7%)		3/19 (15.8%)		4/16 (25%)		0/14 (0%)		57/490 (11.6%)
Rash macular	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Rash maculo-papular	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		3/6 (50%)		2/6 (33.3%)		1/6 (16.7%)		1/5 (20%)		0/6 (0%)		2/20 (10%)		1/6 (16.7%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		1/6 (16.7%)		0/6 (0%)		2/20 (10%)		1/20 (5%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		1/21 (4.8%)		1/22 (4.5%)		1/22 (4.5%)		0/19 (0%)		2/16 (12.5%)		0/14 (0%)		24/490 (4.9%)
Rash pruritic	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		1/6 (16.7%)		1/12 (8.3%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		3/41 (7.3%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		10/490 (2%)
Skin exfoliation	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Skin lesion	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		1/12 (8.3%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Skin mass	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		3/490 (0.6%)
Skin ulcer	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Urticaria	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		1/20 (5%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Vitiligo	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		3/20 (15%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		2/22 (9.1%)		0/19 (0%)		1/16 (6.3%)		0/14 (0%)		6/490 (1.2%)
Xeroderma	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Vascular disorders
Deep vein thrombosis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		1/24 (4.2%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		1/21 (4.8%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Embolism	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		5/490 (1%)
Flushing	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		1/6 (16.7%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		2/41 (4.9%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		8/490 (1.6%)
Haematoma	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Haemorrhage	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		1/14 (7.1%)		1/490 (0.2%)
Hot flush	1/13 (7.7%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		1/11 (9.1%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		1/21 (4.8%)		0/21 (0%)		0/22 (0%)		1/22 (4.5%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		4/490 (0.8%)
Hypertension	0/13 (0%)		2/12 (16.7%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		3/25 (12%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/5 (20%)		3/6 (50%)		4/20 (20%)		1/6 (16.7%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		1/19 (5.3%)		4/41 (9.8%)		5/21 (23.8%)		0/21 (0%)		2/22 (9.1%)		2/22 (9.1%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		34/490 (6.9%)
Hypotension	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		2/6 (33.3%)		1/25 (4%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		3/11 (27.3%)		0/5 (0%)		2/6 (33.3%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		2/20 (10%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		3/6 (50%)		2/11 (18.2%)		0/6 (0%)		0/6 (0%)		1/20 (5%)		0/20 (0%)		0/19 (0%)		1/41 (2.4%)		0/21 (0%)		0/21 (0%)		1/22 (4.5%)		1/22 (4.5%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		22/490 (4.5%)
Lymphoedema	0/13 (0%)		1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/25 (4%)		2/24 (8.3%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/20 (5%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		2/21 (9.5%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		7/490 (1.4%)
Orthostatic hypotension	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/11 (9.1%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		1/19 (5.3%)		0/16 (0%)		0/14 (0%)		2/490 (0.4%)
Peripheral venous disease	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		1/12 (8.3%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Superior vena cava syndrome	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		0/6 (0%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		1/19 (5.3%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)
Thrombophlebitis	0/13 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/25 (0%)		0/24 (0%)		0/4 (0%)		0/5 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/11 (0%)		0/5 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/20 (0%)		0/6 (0%)		0/12 (0%)		0/7 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/11 (0%)		1/6 (16.7%)		0/6 (0%)		0/20 (0%)		0/20 (0%)		0/19 (0%)		0/41 (0%)		0/21 (0%)		0/21 (0%)		0/22 (0%)		0/22 (0%)		0/19 (0%)		0/16 (0%)		0/14 (0%)		1/490 (0.2%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.