Trial Outcomes & Findings for Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma (NCT NCT02811861)

NCT ID: NCT02811861

Last Updated: 2026-01-08

Results Overview

PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1069 participants
• Primary outcome timeframe: From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)
• Results posted on: 2026-01-08

Participant Flow

Participants took part in the study at 181 investigative sites in Austria, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland, the United States of America, Australia, Czechia, Israel, Japan, Korea, Russian Federation, from 13 October 2016 to 28 August 2020 (date of data cutoff for the primary analysis of PFS and second interim analysis of Overall Survival).

A total of 1417 participants were screened, of which, 1069 were randomized. Of the 1069 randomized, 1047 participants were treated in the study.

Participant milestones

Measure	Lenvatinib 18 mg Plus Everolimus 5 mg Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	Lenvatinib 20 mg Plus Pembrolizumab 200 mg Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.	Sunitinib 50 mg Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
Overall Study STARTED	357	355	357
Overall Study Treated	355	352	340
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	357	355	357

Reasons for withdrawal

Measure	Lenvatinib 18 mg Plus Everolimus 5 mg Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	Lenvatinib 20 mg Plus Pembrolizumab 200 mg Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.	Sunitinib 50 mg Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
Overall Study Radiological Disease Progression	123	97	174
Overall Study Clinical Disease Progression	20	19	22
Overall Study Adverse Event	63	60	41
Overall Study Lost to Follow-up	0	0	1
Overall Study Subject Choice	29	17	23
Overall Study Withdrawal by Subject	4	4	9
Overall Study Other	4	13	3
Overall Study Treatment Ongoing at Cutoff Date	112	142	67
Overall Study Randomized but not treated	2	3	17

Baseline Characteristics

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Baseline characteristics by cohort

Measure	Lenvatinib 18 mg Plus Everolimus 5 mg n=357 Participants Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	Lenvatinib 20 mg Plus Pembrolizumab 200 mg n=355 Participants Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.	Sunitinib 50 mg n=357 Participants Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	Total n=1069 Participants Total of all reporting groups
Age, Continuous	61.9 years STANDARD_DEVIATION 10.86 • n=18 Participants	62.3 years STANDARD_DEVIATION 10.23 • n=17 Participants	60.8 years STANDARD_DEVIATION 9.96 • n=35 Participants	61.7 years STANDARD_DEVIATION 10.36 • n=42 Participants
Sex: Female, Male Female	91 Participants n=18 Participants	100 Participants n=17 Participants	82 Participants n=35 Participants	273 Participants n=42 Participants
Sex: Female, Male Male	266 Participants n=18 Participants	255 Participants n=17 Participants	275 Participants n=35 Participants	796 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=18 Participants	12 Participants n=17 Participants	20 Participants n=35 Participants	55 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	328 Participants n=18 Participants	339 Participants n=17 Participants	334 Participants n=35 Participants	1001 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=18 Participants	4 Participants n=17 Participants	3 Participants n=35 Participants	13 Participants n=42 Participants
Race/Ethnicity, Customized White	254 Participants n=18 Participants	263 Participants n=17 Participants	270 Participants n=35 Participants	787 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=18 Participants	2 Participants n=17 Participants	3 Participants n=35 Participants	6 Participants n=42 Participants
Race/Ethnicity, Customized Asian	77 Participants n=18 Participants	81 Participants n=17 Participants	67 Participants n=35 Participants	225 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Other	7 Participants n=18 Participants	4 Participants n=17 Participants	7 Participants n=35 Participants	18 Participants n=42 Participants
Race/Ethnicity, Customized Missing	16 Participants n=18 Participants	5 Participants n=17 Participants	10 Participants n=35 Participants	31 Participants n=42 Participants

PRIMARY outcome

Timeframe: From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)

Population: The FAS included all randomized participants regardless of the treatment actually received.

PFS assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or death (whichever occurred first) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.

Outcome measures

Measure	Lenvatinib 18 mg Plus Everolimus 5 mg n=357 Participants Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	Lenvatinib 20 mg Plus Pembrolizumab 200 mg n=355 Participants Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.	Sunitinib 50 mg n=357 Participants Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
Progression-free Survival (PFS) by Independent Imaging Review (IIR)	14.7 months Interval 11.1 to 16.7	23.9 months Interval 20.8 to 27.7	9.2 months Interval 6.0 to 11.0

SECONDARY outcome

Timeframe: Up to approximately 69 months

ORR is defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by IIR using RECIST 1.1. CR is defined as disappearance of all (targeted and non-target [NT]) lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

OS is defined as the time from the date of randomization to the date of death from any cause. Participants who were lost to follow-up and those who were alive at the data cutoff date were censored, either at the last date the participant was last known alive or at the data cutoff date, whichever occurred first. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug.An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

Time to treatment failure due to toxicity is defined as time from the date of randomization to the date that a participant discontinued study treatment due to TEAEs. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

The FKSI-DRS consisted of 9 items that experts and participants had indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts had indicated are primarily disease-related, as opposed to treatment-related. Symptoms assessed on the FKSI-DRS included lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or hematuria. Each item was scored on a 5-point Likert-type scale (0 = not at all; 4 = very much) where total score ranged from 0 (worst) to 36 (best), where higher scores correspond to better outcomes. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

EORTC QLQ-C30 is a questionnaire including 30 questions that rate the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. For the overall HRQoL and functioning scales, a higher score is correlated with better HRQoL, whereas a higher score represents worse HRQoL for symptom scales. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

EQ-5D-3L is a health profile questionnaire consisting of the EQ-5D descriptive system and the EuroQol visual analog scale (EQ-VAS). For the EQ-5D, participants rate 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at 1 of 3 levels (1=no problems; 2=some problems; 3=extreme problems). The EQ-5D Health Utilities Index (HUI) is derived from the five dimensions of the EQ-5D, using country-specific preference weights (tariffs) to summarize how good or bad each health state is on a scale from 1 (full health) to <0 (worse health/dead). The EQ-VAS measures self-rated global health status using a vertically oriented VAS, where 100 represents the "best imaginable health state" and 0 represents the "worst imaginable health state." Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

PFS2 is defined as the time from randomization to disease progression as assessed by investigator on next-line treatment or death from any cause (whichever occurred first). Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 69 months

PFS by investigator assessment is defined as the time from the date of randomization to the date of first documentation of disease progression based on the investigator assessment per RECIST 1.1 or death (whichever occurred first). Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2 Day 1; 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycles 3, 4, 5 and 6 Day 1: predose (Cycle length=21 days)

Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1 and 2 Day 1; 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycles 3, 4, 5 and 6 Day 1: predose (Cycle length = 21 days

Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2026)

Outcome measures

Outcome data not reported

Adverse Events

Lenvatinib 18 mg Plus Everolimus 5 mg

Serious events: 164 serious events

Other events: 353 other events

Deaths: 119 deaths

Lenvatinib 20 mg Plus Pembrolizumab 200 mg

Serious events: 178 serious events

Other events: 351 other events

Deaths: 78 deaths

Sunitinib 50 mg

Serious events: 113 serious events

Other events: 332 other events

Deaths: 99 deaths

Serious adverse events

Measure	Lenvatinib 18 mg Plus Everolimus 5 mg n=355 participants at risk Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	Lenvatinib 20 mg Plus Pembrolizumab 200 mg n=352 participants at risk Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.	Sunitinib 50 mg n=340 participants at risk Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
Blood and lymphatic system disorders Anaemia	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.2% 4/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Eosinophilia myalgia syndrome	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.5% 5/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Acute coronary syndrome	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.4% 5/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Angina unstable	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Arrhythmia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Atrial flutter	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Bradycardia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac arrest	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac failure	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac failure acute	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiogenic shock	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Cardiomyopathy	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Congestive cardiomyopathy	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Myocardial infarction	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.7% 6/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Myocarditis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Pericardial effusion	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Postinfarction angina	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Stress cardiomyopathy	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Tachycardia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Cardiac disorders Ventricular arrhythmia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.0% 7/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Hypophysitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Hypopituitarism	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Hypothyroidism	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.85% 3/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Secondary hypothyroidism	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Steroid withdrawal syndrome	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Eye disorders Cataract	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Eye disorders Eyelid ptosis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Eye disorders Retinal vascular occlusion	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Eye disorders Retinal vein occlusion	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Eye disorders Vogt-Koyanagi-Harada disease	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal hernia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	1.7% 6/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.4% 5/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Anal fissure	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Anal fistula	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Ascites	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Colitis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Colonic fistula	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Constipation	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.85% 3/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Diarrhoea	3.9% 14/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.4% 12/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.2% 4/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Diverticular perforation	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Enteritis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Enterocolitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Eosinophilic gastritis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Food poisoning	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastric ulcer	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastritis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastroduodenal haemorrhage	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Haematemesis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Ileus	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Immune-mediated pancreatitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Inguinal hernia	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Intestinal obstruction	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Intestinal perforation	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Large intestinal haemorrhage	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Large intestine perforation	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Mallory-Weiss syndrome	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Mechanical ileus	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Melaena	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	1.4% 5/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.4% 5/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Odynophagia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Pancreatitis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.7% 6/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Pancreatitis acute	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Proctitis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Subileus	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	2.8% 10/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.8% 10/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.88% 3/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Asthenia	1.1% 4/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.2% 4/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Death	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Face oedema	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Fatigue	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders General physical health deterioration	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.88% 3/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Generalised oedema	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Inadequate analgesia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Malaise	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Multiple organ dysfunction syndrome	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Non-cardiac chest pain	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Oedema	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Oedema peripheral	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Pain	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Pyrexia	1.1% 4/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.7% 6/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.1% 7/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Bile duct obstruction	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Bile duct stone	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Biliary colic	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholecystitis	1.4% 5/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholecystitis acute	2.3% 8/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholecystitis chronic	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholelithiasis	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.1% 4/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Abdominal infection	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Acute sinusitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Anal abscess	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Appendicitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Bacteraemia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Bronchitis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Cellulitis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Cholecystitis infective	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Clostridium difficile infection	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Colonic abscess	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Diverticulitis	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Ear infection	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Empyema	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Encephalitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Encephalitis viral	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Enteritis infectious	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Enterocolitis infectious	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Gastroenteritis	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Gastroenteritis viral	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Infection	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Infectious pleural effusion	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Influenza	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Klebsiella sepsis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Localised infection	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Necrotising fasciitis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Osteomyelitis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Otitis externa	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Peritonitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Peritonitis bacterial	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Peritonsillar abscess	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Pharyngitis	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia	4.2% 15/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.0% 7/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.8% 6/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia influenzal	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Pneumonia necrotising	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Postoperative wound infection	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Prostatic abscess	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Pyelonephritis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Respiratory tract infection	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Retroperitoneal abscess	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Sepsis	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.85% 3/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.88% 3/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Septic arthritis staphylococcal	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Sinusitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Skin infection	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.1% 4/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.2% 4/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Urosepsis	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Wound infection	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Fall	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Femur fracture	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Head injury	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Lower limb fracture	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Radiation injury	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Radiation proctitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Stress fracture	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Toxicity to various agents	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Alanine aminotransferase increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Amylase increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood bilirubin increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood calcium increased	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood creatinine increased	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Ejection fraction decreased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Electrocardiogram T wave inversion	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Electrocardiogram change	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Glomerular filtration rate decreased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Haemoglobin increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Hepatic enzyme increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Lipase increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.1% 4/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Neutrophil count decreased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Platelet count decreased	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Transaminases increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Troponin increased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Weight decreased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations White blood cell count decreased	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Decreased appetite	1.1% 4/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.85% 3/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Dehydration	1.1% 4/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.2% 4/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Electrolyte imbalance	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypercalcaemia	1.4% 5/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyponatraemia	1.1% 4/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.2% 4/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Bone lesion	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Pathological fracture	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.7% 6/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) External ear neoplasm malignant	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to chest wall	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Ataxia	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Carotid artery stenosis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebral ischaemia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Cerebrovascular accident	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Cytotoxic oedema	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dementia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Depressed level of consciousness	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dysgeusia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Encephalopathy	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Generalised tonic-clonic seizure	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Haemorrhage intracranial	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Hypertensive encephalopathy	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Ischaemic stroke	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Loss of consciousness	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Myasthenic syndrome	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Noninfective encephalitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Paralysis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Paralysis recurrent laryngeal nerve	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Paraparesis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Seizure	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Somnolence	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Spinal cord compression	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Syncope	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Transient ischaemic attack	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Product Issues Device deposit issue	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Confusional state	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Delirium	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Mania	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Mental status changes	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.4% 5/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Acute kidney injury	2.8% 10/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.3% 8/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.5% 5/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Haematuria	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.2% 4/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Nephritis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.85% 3/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Oliguria	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Proteinuria	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Renal failure	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.1% 4/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Renal haemorrhage	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Ureterolithiasis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Urinary retention	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Reproductive system and breast disorders Scrotal pain	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 6/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.0% 7/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.1% 4/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.5% 5/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.6% 9/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.85% 3/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.4% 5/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.88% 3/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Rash	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Surgical and medical procedures Spinal laminectomy	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Aneurysm ruptured	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Aortic dissection	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Aortic stenosis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.57% 2/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Embolism venous	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Haematoma	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertension	0.56% 2/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.3% 8/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertensive crisis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypotension	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.59% 2/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Peripheral ischaemia	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.28% 1/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Phlebitis	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Thrombophlebitis migrans	0.00% 0/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.29% 1/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Hepatobiliary disorders Cholestasis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.

Other adverse events

Measure	Lenvatinib 18 mg Plus Everolimus 5 mg n=355 participants at risk Participants received lenvatinib 18 milligrams (mg) administered orally, once daily in each 21-day cycle, plus everolimus 5 mg administered orally, once daily in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.	Lenvatinib 20 mg Plus Pembrolizumab 200 mg n=352 participants at risk Participants received lenvatinib 20 mg administered orally, once daily in each 21-day cycle, plus pembrolizumab 200 mg administered intravenously, every 3 weeks in each 21-day cycle until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.	Sunitinib 50 mg n=340 participants at risk Participants received sunitinib 50 mg administered orally, once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off treatment until participant had disease progression, development of unacceptable toxicity, participant request, withdrawal of consent.
Gastrointestinal disorders Diarrhoea	65.6% 233/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	60.8% 214/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	48.8% 166/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Stomatitis	47.6% 169/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	34.7% 122/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	38.5% 131/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Nausea	39.2% 139/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	35.5% 125/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	33.2% 113/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Vomiting	30.1% 107/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	25.9% 91/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	19.7% 67/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Constipation	20.6% 73/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	24.7% 87/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	18.8% 64/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain	20.3% 72/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	20.5% 72/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.2% 28/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Dyspepsia	9.6% 34/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.1% 39/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	16.2% 55/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal pain upper	12.7% 45/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	9.7% 34/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.6% 26/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Dry mouth	6.5% 23/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	10.2% 36/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.2% 11/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.5% 16/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.5% 16/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.8% 30/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Toothache	6.8% 24/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.4% 19/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.6% 9/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Haemorrhoids	5.4% 19/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.7% 20/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.2% 11/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Gastrointestinal disorders Abdominal discomfort	5.4% 19/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.3% 8/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.4% 8/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Fatigue	42.0% 149/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	40.1% 141/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	36.5% 124/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Asthenia	17.7% 63/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	21.9% 77/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	17.9% 61/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Oedema peripheral	20.3% 72/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.9% 42/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	10.3% 35/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
General disorders Pyrexia	12.4% 44/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	13.6% 48/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	12.1% 41/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Weight decreased	32.7% 116/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	29.8% 105/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	9.1% 31/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Platelet count decreased	16.6% 59/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.0% 21/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	17.9% 61/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Lipase increased	6.2% 22/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	18.2% 64/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	12.9% 44/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Aspartate aminotransferase increased	14.6% 52/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.1% 39/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	10.9% 37/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Alanine aminotransferase increased	13.8% 49/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.9% 42/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	10.3% 35/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood creatinine increased	10.1% 36/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	13.6% 48/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	10.0% 34/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Amylase increased	4.5% 16/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	17.6% 62/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.2% 28/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood thyroid stimulating hormone increased	6.2% 22/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.1% 39/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 21/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood cholesterol increased	11.5% 41/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.8% 24/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.1% 14/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Neutrophil count decreased	3.9% 14/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.0% 7/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.8% 40/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood triglycerides increased	5.9% 21/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 22/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.4% 15/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations White blood cell count decreased	3.1% 11/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.6% 9/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	9.7% 33/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood creatine phosphokinase increased	5.4% 19/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.0% 14/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.0% 17/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Electrocardiogram QT prolonged	4.2% 15/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 22/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.8% 13/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Investigations Blood alkaline phosphatase increased	5.6% 20/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.8% 17/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.6% 9/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	22.8% 81/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	28.7% 101/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	37.4% 127/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Rash	24.5% 87/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	27.0% 95/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	13.8% 47/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Pruritus	13.2% 47/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	16.5% 58/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.6% 26/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Dry skin	8.7% 31/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 22/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.9% 27/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.5% 23/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.0% 28/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.1% 7/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Yellow skin	0.28% 1/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	9.4% 32/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	6.5% 23/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.4% 5/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.88% 3/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Decreased appetite	40.3% 143/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	40.3% 142/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	30.9% 105/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	22.5% 80/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.9% 42/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	12.1% 41/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	10.4% 37/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.8% 31/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.1% 7/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperglycaemia	8.7% 31/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.8% 24/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.3% 18/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypophosphataemia	9.0% 32/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 22/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.4% 15/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyponatraemia	4.8% 17/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.7% 27/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.9% 20/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypokalaemia	8.5% 30/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 22/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.2% 11/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hyperkalaemia	3.9% 14/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.7% 27/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.3% 18/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	21.1% 75/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	28.1% 99/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	15.3% 52/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Back pain	16.9% 60/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	16.2% 57/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	15.3% 52/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.0% 39/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	13.6% 48/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 21/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	9.3% 33/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.6% 41/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	9.7% 33/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Myalgia	9.6% 34/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	15.9% 56/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.5% 12/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	3.9% 14/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.8% 24/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.5% 12/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.6% 20/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.5% 16/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.2% 11/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Cough	23.7% 84/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	19.9% 70/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	15.6% 53/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	23.7% 84/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	29.8% 105/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.1% 14/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.1% 50/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	14.5% 51/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	9.4% 32/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	19.7% 70/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.1% 25/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	10.9% 37/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.3% 33/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.5% 23/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.5% 12/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.4% 19/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.4% 12/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	0.00% 0/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypertension	45.6% 162/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	55.1% 194/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	41.5% 141/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Vascular disorders Hypotension	4.8% 17/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.8% 24/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.8% 6/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Nasopharyngitis	9.6% 34/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.4% 40/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.4% 25/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Urinary tract infection	9.0% 32/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.8% 24/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.8% 23/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Sinusitis	3.9% 14/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.4% 19/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.8% 6/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Headache	22.8% 81/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	22.7% 80/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	15.9% 54/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dysgeusia	16.6% 59/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	11.9% 42/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	27.9% 95/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Nervous system disorders Dizziness	4.8% 17/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	9.7% 34/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.5% 29/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Haematuria	4.2% 15/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.8% 17/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	5.6% 19/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Hypothyroidism	26.8% 95/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	46.6% 164/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	26.5% 90/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Endocrine disorders Hyperthyroidism	2.5% 9/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.0% 28/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.5% 12/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Anaemia	16.1% 57/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	12.2% 43/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	19.4% 66/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Thrombocytopenia	11.0% 39/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	4.0% 14/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	15.6% 53/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Neutropenia	3.1% 11/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	2.6% 9/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	13.5% 46/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Blood and lymphatic system disorders Leukopenia	1.1% 4/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	1.4% 5/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.8% 23/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Psychiatric disorders Insomnia	11.3% 40/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	10.8% 38/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 21/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Metabolism and nutrition disorders Hypomagnesaemia	4.8% 17/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	7.7% 27/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	3.8% 13/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Infections and infestations Upper respiratory tract infection	6.8% 24/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	8.8% 31/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	6.2% 21/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.
Renal and urinary disorders Proteinuria	34.1% 121/355 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	29.5% 104/352 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.	12.6% 43/340 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug or up to data cutoff date 28 Aug 2020 (up to approximately 46 months) Safety analysis set included all participants who received at least 1 dose of any study drug.

Additional Information

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