Trial Outcomes & Findings for Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067) (NCT NCT01844505)

NCT ID: NCT01844505

Last Updated: 2025-05-21

Results Overview

PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 945 participants
• Primary outcome timeframe: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)
• Results posted on: 2025-05-21

Participant Flow

Participant milestones

Measure	Nivolumab Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Pre-Treatment Period STARTED	316	314	315
Pre-Treatment Period COMPLETED	313	313	311
Pre-Treatment Period NOT COMPLETED	3	1	4
Treatment Period STARTED	313	313	311
Treatment Period COMPLETED	0	0	0
Treatment Period NOT COMPLETED	313	313	311

Reasons for withdrawal

Measure	Nivolumab Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Treatment Period SUBJECT WITHDREW CONSENT	9	12	19
Treatment Period Other Reasons	120	136	58
Treatment Period Lost to Follow-up	9	11	6
Treatment Period Death	175	154	228

Baseline Characteristics

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Baseline characteristics by cohort

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses	Total n=945 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 13.92 • n=5 Participants	59.3 years STANDARD_DEVIATION 13.86 • n=7 Participants	60.8 years STANDARD_DEVIATION 13.23 • n=5 Participants	59.6 years STANDARD_DEVIATION 13.69 • n=4 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	108 Participants n=7 Participants	113 Participants n=5 Participants	335 Participants n=4 Participants
Sex: Female, Male Male	202 Participants n=5 Participants	206 Participants n=7 Participants	202 Participants n=5 Participants	610 Participants n=4 Participants
Race/Ethnicity, Customized WHITE	308 Participants n=5 Participants	310 Participants n=7 Participants	303 Participants n=5 Participants	921 Participants n=4 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized ASIAN	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized OTHER	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized NOT REPORTED	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)

Population: All randomized participants

PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Progression Free Survival (PFS)	6.87 months Interval 4.34 to 9.46	11.50 months Interval 8.9 to 16.72	2.89 months Interval 2.79 to 3.42

PRIMARY outcome

Timeframe: From randomization to date of death (Assessed up to September 2016, approximately 39 months)

Population: All randomized participants

OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Overall Survival (OS)	NA months Interval 29.08 to Median OS was not reached	NA months Median OS was not reached	19.98 months Interval 17.08 to 24.61

PRIMARY outcome

Timeframe: 24 months

Population: All randomized participants

OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Rate of Overall Survival Rate of OS at 6 months	0.85 Probability of survival at Time T Interval 0.81 to 0.89	0.86 Probability of survival at Time T Interval 0.81 to 0.89	0.82 Probability of survival at Time T Interval 0.78 to 0.86
Rate of Overall Survival Rate of OS at 12 months	0.74 Probability of survival at Time T Interval 0.69 to 0.79	0.73 Probability of survival at Time T Interval 0.68 to 0.78	0.67 Probability of survival at Time T Interval 0.61 to 0.72
Rate of Overall Survival Rate of OS at 24 months	0.59 Probability of survival at Time T Interval 0.53 to 0.64	0.64 Probability of survival at Time T Interval 0.59 to 0.69	0.45 Probability of survival at Time T Interval 0.39 to 0.5

PRIMARY outcome

Timeframe: 24 months

Population: All randomized participants

PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Rate of Progression-Free Survival Rate at 6 months	0.52 Percentage of participants Interval 0.46 to 0.58	0.63 Percentage of participants Interval 0.57 to 0.68	0.28 Percentage of participants Interval 0.23 to 0.33
Rate of Progression-Free Survival Rate at 12 months	0.43 Percentage of participants Interval 0.37 to 0.49	0.50 Percentage of participants Interval 0.44 to 0.55	0.18 Percentage of participants Interval 0.14 to 0.22
Rate of Progression-Free Survival Rate at 24 months	0.37 Percentage of participants Interval 0.31 to 0.43	0.43 Percentage of participants Interval 0.37 to 0.48	0.12 Percentage of participants Interval 0.09 to 0.17

SECONDARY outcome

Timeframe: From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)

Population: All randomized participants

PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Progression Free Survival (PFS)	6.93 months Interval 5.13 to 10.18	11.50 months Interval 8.9 to 20.04	2.86 months Interval 2.79 to 3.09

SECONDARY outcome

Timeframe: From randomization until death (assessed up to approximately 128 months)

Population: All randomized participants

OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Overall Survival (OS)	36.93 months Interval 28.25 to 58.71	71.92 months Interval 38.18 to 114.37	19.94 months Interval 16.85 to 24.61

SECONDARY outcome

Timeframe: From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)

Population: All randomized participants

The ORR was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Objective Response Rate (ORR) Per Investigator Assessment	44.9 Percentage of participants Interval 39.4 to 50.6	58.3 Percentage of participants Interval 52.6 to 63.8	19.0 Percentage of participants Interval 14.9 to 23.8

SECONDARY outcome

Timeframe: From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)

Population: All randomized participants with evaluable PD-L1 expression level at baseline

PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 >=5% or PD-L1 <5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Progression-Free Survival Based on PD-L1 Expression Level PD-L1 >= 10% (n= 59, 46, 54)	21.98 months Interval 9.07 to Upper 95% Confidence Interval was not reached.	NA months Interval 13.96 to Median and upper 95% Confidence Interval were not reached.	4.11 months Interval 2.79 to 5.59
Progression-Free Survival Based on PD-L1 Expression Level PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38)	2.99 months Interval 2.66 to 6.93	6.93 months Interval 2.79 to 20.04	2.83 months Interval 2.6 to 6.41
Progression-Free Survival Based on PD-L1 Expression Level PD-L1 < 1% (n=117, 123, 113)	2.83 months Interval 2.76 to 5.39	11.17 months Interval 6.93 to 26.68	2.76 months Interval 2.66 to 2.86
Progression-Free Survival Based on PD-L1 Expression Level PD-L1 >= 1% (n= 171, 155, 164)	16.20 months Interval 8.11 to 27.66	16.72 months Interval 9.72 to Upper 95% Confidence Interval was not reached.	3.48 months Interval 2.83 to 4.17
Progression-Free Survival Based on PD-L1 Expression Level PD-L1 < 5% (n= 208, 210, 202)	5.32 months Interval 2.96 to 6.87	11.17 months Interval 8.31 to 22.18	2.83 months Interval 2.76 to 3.02
Progression-Free Survival Based on PD-L1 Expression Level PD-L1 >= 5% (n= 80, 68, 75)	22.34 months Interval 9.46 to Upper 95% Confidence Interval was not reached.	22.11 months Interval 9.72 to Upper 95% Confidence Interval was not reached.	3.94 months Interval 2.79 to 4.21
Progression-Free Survival Based on PD-L1 Expression Level PD-L1 < 10% (n= 229, 232, 223)	5.62 months Interval 3.09 to 8.87	11.10 months Interval 8.02 to 18.14	2.83 months Interval 2.76 to 3.02

SECONDARY outcome

Timeframe: From randomization until death (assessed up to approximately 128 months)

Population: All randomized participants with evaluable PD-L1 expression level at baseline

OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Overall Survival Based on PD-L1 Expression Level PD-L1 < 1% (n=117, 123, 113)	23.46 months Interval 13.01 to Upper 95% Confidence Interval was not reached	NA months Interval 26.45 to Upper 95% Confidence Interval was not reached	18.56 months Interval 13.67 to 23.2
Overall Survival Based on PD-L1 Expression Level PD-L1 >= 5% (n= 80, 68, 75)	64.51 months Interval 33.64 to Upper 95% Confidence Interval was not reached	104.97 months Interval 39.06 to Upper 95% Confidence Interval was not reached	28.88 months Interval 18.1 to 44.16
Overall Survival Based on PD-L1 Expression Level PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38)	23.89 months Interval 11.76 to Upper 95% Confidence Interval was not reached	NA months Interval 21.39 to Median and Upper 95% Confidence Interval were not reached	18.73 months Interval 8.41 to 30.0
Overall Survival Based on PD-L1 Expression Level PD-L1 >= 1% (n= 171, 155, 164)	85.09 months Interval 39.0 to Upper 95% Confidence Interval was not reached	82.30 months Interval 39.06 to Upper 95% Confidence Interval was not reached	21.49 months Interval 16.85 to 29.08
Overall Survival Based on PD-L1 Expression Level PD-L1 < 5% (n= 208, 210, 202)	35.94 months Interval 23.06 to 59.24	65.94 months Interval 32.72 to 114.37	18.40 months Interval 13.7 to 22.51
Overall Survival Based on PD-L1 Expression Level PD-L1 < 10% (n= 229, 232, 223)	36.93 months Interval 23.46 to 80.85	70.74 months Interval 34.83 to 107.89	18.56 months Interval 14.98 to 23.03
Overall Survival Based on PD-L1 Expression Level PD-L1 >= 10% (n= 59, 46, 54)	43.63 months Interval 31.24 to Upper 95% Confidence Interval was not reached	NA months Interval 39.06 to Upper 95% Confidence Interval was not reached	29.08 months Interval 17.45 to 46.55

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.

Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 13 (n= 195, 106, 130)	-1.9 Points on EORTC scale Standard Deviation 16.44	-3.8 Points on EORTC scale Standard Deviation 21.21	-5.5 Points on EORTC scale Standard Deviation 20.27
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 17 (n= 158, 84, 104)	-1.6 Points on EORTC scale Standard Deviation 19.73	-6.0 Points on EORTC scale Standard Deviation 22.01	-6.1 Points on EORTC scale Standard Deviation 16.80
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 19 (n= 164, 96, 98)	-0.8 Points on EORTC scale Standard Deviation 18.30	-0.8 Points on EORTC scale Standard Deviation 21.70	-5.4 Points on EORTC scale Standard Deviation 19.52
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 37 (n= 116, 88, 48)	3.2 Points on EORTC scale Standard Deviation 18.44	-0.2 Points on EORTC scale Standard Deviation 21.18	-1.9 Points on EORTC scale Standard Deviation 15.11
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 43 (n= 103, 74, 44)	3.5 Points on EORTC scale Standard Deviation 18.28	-0.5 Points on EORTC scale Standard Deviation 23.04	-0.9 Points on EORTC scale Standard Deviation 15.59
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 67 (n= 76, 61, 29)	2.1 Points on EORTC scale Standard Deviation 17.49	-2.9 Points on EORTC scale Standard Deviation 21.35	-6.6 Points on EORTC scale Standard Deviation 15.17
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 127 (n= 47, 36, 17)	0.9 Points on EORTC scale Standard Deviation 20.06	-1.9 Points on EORTC scale Standard Deviation 22.37	1.5 Points on EORTC scale Standard Deviation 12.92
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 139 (n= 20, 19, 6)	0.0 Points on EORTC scale Standard Deviation 18.73	-4.4 Points on EORTC scale Standard Deviation 17.43	5.6 Points on EORTC scale Standard Deviation 15.52
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 5 (n= 233, 183, 221)	-2.8 Points on EORTC scale Standard Deviation 15.74	-4.3 Points on EORTC scale Standard Deviation 21.38	-3.1 Points on EORTC scale Standard Deviation 17.24
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 7 (n= 239, 183, 218)	-2.6 Points on EORTC scale Standard Deviation 16.89	-5.0 Points on EORTC scale Standard Deviation 20.60	-4.3 Points on EORTC scale Standard Deviation 18.07
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 11 (n= 201, 112, 163)	-2.0 Points on EORTC scale Standard Deviation 18.10	-2.4 Points on EORTC scale Standard Deviation 21.99	-6.2 Points on EORTC scale Standard Deviation 18.73
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 23 (n= 134, 86, 75)	-2.8 Points on EORTC scale Standard Deviation 19.44	-2.6 Points on EORTC scale Standard Deviation 22.00	-3.7 Points on EORTC scale Standard Deviation 16.28
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 25 (n= 144, 97, 75)	1.3 Points on EORTC scale Standard Deviation 17.39	-3.3 Points on EORTC scale Standard Deviation 17.70	-4.2 Points on EORTC scale Standard Deviation 16.52
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 31 (n= 123, 92, 51)	2.5 Points on EORTC scale Standard Deviation 17.40	1.5 Points on EORTC scale Standard Deviation 21.47	2.0 Points on EORTC scale Standard Deviation 15.51
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 49 (n= 97, 70, 40)	2.7 Points on EORTC scale Standard Deviation 16.52	0.6 Points on EORTC scale Standard Deviation 21.95	-0.4 Points on EORTC scale Standard Deviation 15.78
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 55 (n= 86, 66, 34)	1.8 Points on EORTC scale Standard Deviation 14.26	-2.4 Points on EORTC scale Standard Deviation 22.01	0.7 Points on EORTC scale Standard Deviation 13.03
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 61 (n= 85, 61, 31)	1.6 Points on EORTC scale Standard Deviation 16.29	-3.6 Points on EORTC scale Standard Deviation 20.78	0.8 Points on EORTC scale Standard Deviation 11.25
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 73 (n= 67, 54, 19)	0.1 Points on EORTC scale Standard Deviation 19.11	-4.5 Points on EORTC scale Standard Deviation 21.76	-3.5 Points on EORTC scale Standard Deviation 16.97
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 79 (n= 67, 54, 21)	-0.1 Points on EORTC scale Standard Deviation 14.40	-4.8 Points on EORTC scale Standard Deviation 20.51	-0.8 Points on EORTC scale Standard Deviation 14.65
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 85 (n= 68, 51, 18)	2.8 Points on EORTC scale Standard Deviation 16.64	-3.3 Points on EORTC scale Standard Deviation 22.37	0.0 Points on EORTC scale Standard Deviation 10.69
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 91 (n= 62, 53, 16)	0.9 Points on EORTC scale Standard Deviation 17.08	-3.9 Points on EORTC scale Standard Deviation 20.78	0.5 Points on EORTC scale Standard Deviation 12.72
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 97 (n= 58, 49, 17)	0.9 Points on EORTC scale Standard Deviation 17.01	-5.1 Points on EORTC scale Standard Deviation 23.06	-2.9 Points on EORTC scale Standard Deviation 12.13
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 103 (n= 53, 46, 17)	2.2 Points on EORTC scale Standard Deviation 17.61	-9.8 Points on EORTC scale Standard Deviation 19.03	0.0 Points on EORTC scale Standard Deviation 13.50
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 109 (n= 44, 39, 14)	2.8 Points on EORTC scale Standard Deviation 16.56	-3.8 Points on EORTC scale Standard Deviation 23.17	-2.4 Points on EORTC scale Standard Deviation 14.03
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 115 (n= 44, 36, 17)	0.6 Points on EORTC scale Standard Deviation 15.50	-6.9 Points on EORTC scale Standard Deviation 22.76	-0.5 Points on EORTC scale Standard Deviation 11.59
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 121 (n= 44, 39, 16)	1.1 Points on EORTC scale Standard Deviation 19.90	-1.5 Points on EORTC scale Standard Deviation 19.20	-3.1 Points on EORTC scale Standard Deviation 15.18
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 133 (n= 29, 31, 11)	3.2 Points on EORTC scale Standard Deviation 20.70	-2.4 Points on EORTC scale Standard Deviation 25.11	3.8 Points on EORTC scale Standard Deviation 13.10
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 145 (n= 14, 14, 6)	0.6 Points on EORTC scale Standard Deviation 25.42	-8.9 Points on EORTC scale Standard Deviation 8.93	-4.2 Points on EORTC scale Standard Deviation 17.28
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 151 (n= 7, 7, 1)	3.6 Points on EORTC scale Standard Deviation 9.45	-13.1 Points on EORTC scale Standard Deviation 9.45	8.3 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status Week 157 (n= 1, 3, 0)	0.0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed	-16.7 Points on EORTC scale Standard Deviation 8.33	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.

Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 13 (n= 195, 106, 130)	0.6 Points on EORTC scale Standard Deviation 22.73	-3.6 Points on EORTC scale Standard Deviation 20.57	-2.2 Points on EORTC scale Standard Deviation 24.41
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 17 (n= 158, 84, 104)	-0.9 Points on EORTC scale Standard Deviation 22.28	-4.4 Points on EORTC scale Standard Deviation 25.10	-2.9 Points on EORTC scale Standard Deviation 18.06
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 79 (n= 67, 54, 21)	1.2 Points on EORTC scale Standard Deviation 14.01	-3.4 Points on EORTC scale Standard Deviation 24.31	0.8 Points on EORTC scale Standard Deviation 3.64
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 91 (n= 62, 53, 16)	-0.8 Points on EORTC scale Standard Deviation 17.96	-5.7 Points on EORTC scale Standard Deviation 24.23	1.0 Points on EORTC scale Standard Deviation 4.17
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 97 (n= 58, 49, 17)	-0.3 Points on EORTC scale Standard Deviation 16.95	-2.7 Points on EORTC scale Standard Deviation 22.14	0.0 Points on EORTC scale Standard Deviation 0.00
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 139 (n= 20, 19, 6)	4.2 Points on EORTC scale Standard Deviation 10.64	-4.4 Points on EORTC scale Standard Deviation 19.12	2.8 Points on EORTC scale Standard Deviation 16.39
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 121 (n= 44, 39, 16)	3.4 Points on EORTC scale Standard Deviation 19.88	-3.0 Points on EORTC scale Standard Deviation 25.33	-1.0 Points on EORTC scale Standard Deviation 4.17
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 5 (n= 233, 183, 221)	-1.2 Points on EORTC scale Standard Deviation 21.99	-4.6 Points on EORTC scale Standard Deviation 21.76	-1.6 Points on EORTC scale Standard Deviation 21.59
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 7 (n= 239, 183, 218)	-0.1 Points on EORTC scale Standard Deviation 20.58	-5.8 Points on EORTC scale Standard Deviation 21.81	-0.2 Points on EORTC scale Standard Deviation 21.79
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 11 (n= 201, 112, 163)	-0.6 Points on EORTC scale Standard Deviation 22.32	-5.1 Points on EORTC scale Standard Deviation 22.02	-3.4 Points on EORTC scale Standard Deviation 21.53
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 19 (n= 164, 96, 98)	1.4 Points on EORTC scale Standard Deviation 21.40	-1.7 Points on EORTC scale Standard Deviation 23.13	-1.3 Points on EORTC scale Standard Deviation 24.71
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 23 (n= 134, 86, 75)	-0.1 Points on EORTC scale Standard Deviation 19.87	-1.2 Points on EORTC scale Standard Deviation 23.40	-4.2 Points on EORTC scale Standard Deviation 21.94
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 25 (n= 144, 97, 75)	1.2 Points on EORTC scale Standard Deviation 19.77	-3.4 Points on EORTC scale Standard Deviation 21.37	-1.3 Points on EORTC scale Standard Deviation 25.23
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 31 (n= 123, 92, 51)	3.5 Points on EORTC scale Standard Deviation 16.84	0.2 Points on EORTC scale Standard Deviation 20.30	3.6 Points on EORTC scale Standard Deviation 22.68
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 37 (n= 116, 88, 48)	1.6 Points on EORTC scale Standard Deviation 18.12	1.1 Points on EORTC scale Standard Deviation 22.71	3.1 Points on EORTC scale Standard Deviation 18.40
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 43 (n= 103, 74, 44)	-0.2 Points on EORTC scale Standard Deviation 20.68	2.9 Points on EORTC scale Standard Deviation 21.43	4.2 Points on EORTC scale Standard Deviation 22.77
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 49 (n= 97, 70, 40)	2.4 Points on EORTC scale Standard Deviation 17.35	3.1 Points on EORTC scale Standard Deviation 19.92	6.3 Points on EORTC scale Standard Deviation 18.37
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 55 (n= 86, 66, 34)	0.6 Points on EORTC scale Standard Deviation 19.21	0.0 Points on EORTC scale Standard Deviation 21.68	5.9 Points on EORTC scale Standard Deviation 17.83
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 61 (n= 85, 61, 31)	2.7 Points on EORTC scale Standard Deviation 16.44	-0.5 Points on EORTC scale Standard Deviation 22.76	5.9 Points on EORTC scale Standard Deviation 17.51
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 67 (n= 76, 61, 29)	1.8 Points on EORTC scale Standard Deviation 16.46	-0.8 Points on EORTC scale Standard Deviation 24.80	-2.3 Points on EORTC scale Standard Deviation 17.66
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 73 (n= 67, 54, 19)	1.5 Points on EORTC scale Standard Deviation 17.58	-2.5 Points on EORTC scale Standard Deviation 17.85	-8.8 Points on EORTC scale Standard Deviation 18.73
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 85 (n= 68, 51, 18)	1.0 Points on EORTC scale Standard Deviation 13.77	-7.5 Points on EORTC scale Standard Deviation 21.68	-1.9 Points on EORTC scale Standard Deviation 7.86
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 103 (n= 53, 46, 17)	-0.6 Points on EORTC scale Standard Deviation 17.28	-4.3 Points on EORTC scale Standard Deviation 22.62	-1.0 Points on EORTC scale Standard Deviation 4.04
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 109 (n= 44, 39, 14)	4.2 Points on EORTC scale Standard Deviation 15.72	-2.6 Points on EORTC scale Standard Deviation 20.43	-3.6 Points on EORTC scale Standard Deviation 9.65
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 115 (n= 44, 36, 17)	3.8 Points on EORTC scale Standard Deviation 18.63	-2.3 Points on EORTC scale Standard Deviation 25.56	0.0 Points on EORTC scale Standard Deviation 5.89
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 127 (n= 47, 36, 17)	3.5 Points on EORTC scale Standard Deviation 18.37	-2.3 Points on EORTC scale Standard Deviation 22.24	2.0 Points on EORTC scale Standard Deviation 5.54
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 133 (n= 29, 31, 11)	0.6 Points on EORTC scale Standard Deviation 15.74	-2.2 Points on EORTC scale Standard Deviation 26.44	3.0 Points on EORTC scale Standard Deviation 10.05
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 145 (n= 14, 14, 6)	-8.3 Points on EORTC scale Standard Deviation 26.75	-11.9 Points on EORTC scale Standard Deviation 16.57	2.8 Points on EORTC scale Standard Deviation 16.39
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 151 (n= 7, 7, 1)	7.1 Points on EORTC scale Standard Deviation 23.29	-9.5 Points on EORTC scale Standard Deviation 16.27	0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning Week 157 (n= 1, 3, 0)	0.0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed	-22.2 Points on EORTC scale Standard Deviation 19.25	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.

Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 11 (n= 201, 112, 163)	-1.7 Points on EORTC scale Standard Deviation 13.27	-0.1 Points on EORTC scale Standard Deviation 16.67	-4.7 Points on EORTC scale Standard Deviation 15.33
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 23 (n= 134, 86, 75)	-0.6 Points on EORTC scale Standard Deviation 13.31	-4.5 Points on EORTC scale Standard Deviation 21.61	-5.6 Points on EORTC scale Standard Deviation 14.58
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 31 (n= 123, 92, 51)	1.1 Points on EORTC scale Standard Deviation 12.40	-1.6 Points on EORTC scale Standard Deviation 17.13	-3.3 Points on EORTC scale Standard Deviation 12.48
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 55 (n= 86, 66, 34)	0.4 Points on EORTC scale Standard Deviation 13.52	-2.8 Points on EORTC scale Standard Deviation 14.79	-2.5 Points on EORTC scale Standard Deviation 12.40
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 5 (n= 233, 183, 221)	0.1 Points on EORTC scale Standard Deviation 12.28	-2.1 Points on EORTC scale Standard Deviation 16.49	-0.2 Points on EORTC scale Standard Deviation 13.99
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 7 (n= 239, 183, 218)	-1.7 Points on EORTC scale Standard Deviation 12.80	-3.6 Points on EORTC scale Standard Deviation 16.26	-1.5 Points on EORTC scale Standard Deviation 13.36
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 13 (n= 195, 106, 130)	-0.9 Points on EORTC scale Standard Deviation 13.45	-0.3 Points on EORTC scale Standard Deviation 14.36	-2.3 Points on EORTC scale Standard Deviation 14.64
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 17 (n= 158, 84, 104)	-0.9 Points on EORTC scale Standard Deviation 12.79	-3.6 Points on EORTC scale Standard Deviation 19.37	-2.4 Points on EORTC scale Standard Deviation 13.43
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 19 (n= 164, 96, 98)	-1.9 Points on EORTC scale Standard Deviation 13.99	-1.0 Points on EORTC scale Standard Deviation 17.07	-2.2 Points on EORTC scale Standard Deviation 13.39
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 25 (n= 144, 97, 75)	-1.2 Points on EORTC scale Standard Deviation 12.72	-4.8 Points on EORTC scale Standard Deviation 20.26	-2.4 Points on EORTC scale Standard Deviation 12.46
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 37 (n= 116, 88, 48)	1.6 Points on EORTC scale Standard Deviation 11.42	-2.8 Points on EORTC scale Standard Deviation 17.91	-5.6 Points on EORTC scale Standard Deviation 15.88
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 43 (n= 103, 74, 44)	-1.6 Points on EORTC scale Standard Deviation 15.40	-2.9 Points on EORTC scale Standard Deviation 13.89	0.0 Points on EORTC scale Standard Deviation 11.37
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 49 (n= 97, 70, 40)	-1.2 Points on EORTC scale Standard Deviation 12.32	-1.2 Points on EORTC scale Standard Deviation 15.10	0.4 Points on EORTC scale Standard Deviation 12.22
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 61 (n= 85, 61, 31)	0.0 Points on EORTC scale Standard Deviation 14.09	-1.6 Points on EORTC scale Standard Deviation 15.12	-3.2 Points on EORTC scale Standard Deviation 15.76
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 67 (n= 76, 61, 29)	-1.3 Points on EORTC scale Standard Deviation 13.27	-3.0 Points on EORTC scale Standard Deviation 17.35	-7.5 Points on EORTC scale Standard Deviation 16.42
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 73 (n= 67, 54, 19)	-2.2 Points on EORTC scale Standard Deviation 11.20	-4.9 Points on EORTC scale Standard Deviation 19.86	-6.1 Points on EORTC scale Standard Deviation 11.40
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 79 (n= 67, 54, 21)	-0.2 Points on EORTC scale Standard Deviation 12.48	-4.6 Points on EORTC scale Standard Deviation 20.58	-4.8 Points on EORTC scale Standard Deviation 13.06
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 85 (n= 68, 51, 18)	-1.5 Points on EORTC scale Standard Deviation 12.79	-4.2 Points on EORTC scale Standard Deviation 17.90	-2.8 Points on EORTC scale Standard Deviation 13.10
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 91 (n= 62, 53, 16)	-0.5 Points on EORTC scale Standard Deviation 12.06	-4.7 Points on EORTC scale Standard Deviation 19.44	-1.0 Points on EORTC scale Standard Deviation 9.56
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 97 (n= 58, 49, 17)	-3.2 Points on EORTC scale Standard Deviation 14.12	-3.7 Points on EORTC scale Standard Deviation 13.72	-2.0 Points on EORTC scale Standard Deviation 10.00
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 103 (n= 53, 46, 17)	-2.5 Points on EORTC scale Standard Deviation 15.81	-5.8 Points on EORTC scale Standard Deviation 23.63	-5.9 Points on EORTC scale Standard Deviation 15.52
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 109 (n= 44, 39, 14)	1.1 Points on EORTC scale Standard Deviation 10.42	-3.8 Points on EORTC scale Standard Deviation 19.29	-1.2 Points on EORTC scale Standard Deviation 7.91
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 115 (n= 44, 36, 17)	0.4 Points on EORTC scale Standard Deviation 9.84	-3.7 Points on EORTC scale Standard Deviation 15.49	-2.0 Points on EORTC scale Standard Deviation 10.00
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 121 (n= 44, 39, 16)	-1.1 Points on EORTC scale Standard Deviation 14.56	-7.7 Points on EORTC scale Standard Deviation 15.22	-1.0 Points on EORTC scale Standard Deviation 9.56
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 127 (n= 47, 36, 17)	-2.8 Points on EORTC scale Standard Deviation 17.83	-3.2 Points on EORTC scale Standard Deviation 13.10	-1.0 Points on EORTC scale Standard Deviation 13.78
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 133 (n= 29, 31, 11)	-4.6 Points on EORTC scale Standard Deviation 22.67	-3.8 Points on EORTC scale Standard Deviation 13.41	1.5 Points on EORTC scale Standard Deviation 8.99
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 139 (n= 20, 19, 6)	-3.3 Points on EORTC scale Standard Deviation 6.84	-6.1 Points on EORTC scale Standard Deviation 11.40	5.6 Points on EORTC scale Standard Deviation 8.61
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 145 (n= 14, 14, 6)	-11.9 Points on EORTC scale Standard Deviation 29.55	-4.8 Points on EORTC scale Standard Deviation 12.10	-5.6 Points on EORTC scale Standard Deviation 17.21
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 151 (n= 7, 7, 1)	-2.4 Points on EORTC scale Standard Deviation 11.50	-7.1 Points on EORTC scale Standard Deviation 13.11	16.7 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning Week 157 (n= 1, 3, 0)	0.0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed	-11.1 Points on EORTC scale Standard Deviation 9.62	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.

Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 5 (n= 233, 183, 221)	4.6 Points on EORTC scale Standard Deviation 15.91	2.5 Points on EORTC scale Standard Deviation 16.44	3.7 Points on EORTC scale Standard Deviation 17.21
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 145 (n= 14, 14, 6)	2.4 Points on EORTC scale Standard Deviation 18.32	6.0 Points on EORTC scale Standard Deviation 15.82	11.1 Points on EORTC scale Standard Deviation 10.09
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 151 (n= 7, 7, 1)	17.9 Points on EORTC scale Standard Deviation 16.27	-2.4 Points on EORTC scale Standard Deviation 22.93	16.7 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 23 (n= 134, 86, 75)	6.1 Points on EORTC scale Standard Deviation 17.04	4.5 Points on EORTC scale Standard Deviation 20.20	3.7 Points on EORTC scale Standard Deviation 18.85
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 25 (n= 144, 97, 75)	6.6 Points on EORTC scale Standard Deviation 16.31	2.1 Points on EORTC scale Standard Deviation 19.69	5.9 Points on EORTC scale Standard Deviation 17.15
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 31 (n= 123, 92, 51)	8.3 Points on EORTC scale Standard Deviation 15.57	4.7 Points on EORTC scale Standard Deviation 15.64	9.2 Points on EORTC scale Standard Deviation 16.69
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 37 (n= 116, 88, 48)	9.6 Points on EORTC scale Standard Deviation 15.60	6.8 Points on EORTC scale Standard Deviation 17.98	5.9 Points on EORTC scale Standard Deviation 16.75
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 43 (n= 103, 74, 44)	6.7 Points on EORTC scale Standard Deviation 18.89	7.5 Points on EORTC scale Standard Deviation 18.36	6.1 Points on EORTC scale Standard Deviation 14.86
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 49 (n= 97, 70, 40)	5.8 Points on EORTC scale Standard Deviation 18.61	7.1 Points on EORTC scale Standard Deviation 19.67	8.1 Points on EORTC scale Standard Deviation 15.50
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 55 (n= 86, 66, 34)	8.1 Points on EORTC scale Standard Deviation 18.57	8.3 Points on EORTC scale Standard Deviation 16.79	12.3 Points on EORTC scale Standard Deviation 15.11
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 61 (n= 85, 61, 31)	7.9 Points on EORTC scale Standard Deviation 18.54	7.9 Points on EORTC scale Standard Deviation 22.69	9.9 Points on EORTC scale Standard Deviation 14.82
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 67 (n= 76, 61, 29)	7.8 Points on EORTC scale Standard Deviation 19.97	7.1 Points on EORTC scale Standard Deviation 20.52	3.7 Points on EORTC scale Standard Deviation 15.36
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 73 (n= 67, 54, 19)	8.0 Points on EORTC scale Standard Deviation 18.66	4.5 Points on EORTC scale Standard Deviation 18.29	4.8 Points on EORTC scale Standard Deviation 10.51
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 79 (n= 67, 54, 21)	7.6 Points on EORTC scale Standard Deviation 19.56	2.9 Points on EORTC scale Standard Deviation 23.36	6.7 Points on EORTC scale Standard Deviation 10.41
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 85 (n= 68, 51, 18)	6.4 Points on EORTC scale Standard Deviation 16.55	3.3 Points on EORTC scale Standard Deviation 21.09	7.9 Points on EORTC scale Standard Deviation 12.61
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 91 (n= 62, 53, 16)	9.1 Points on EORTC scale Standard Deviation 17.77	4.7 Points on EORTC scale Standard Deviation 20.25	3.6 Points on EORTC scale Standard Deviation 12.53
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 97 (n= 58, 49, 17)	5.3 Points on EORTC scale Standard Deviation 17.78	3.9 Points on EORTC scale Standard Deviation 21.05	3.9 Points on EORTC scale Standard Deviation 14.47
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 103 (n= 53, 46, 17)	6.6 Points on EORTC scale Standard Deviation 19.50	1.4 Points on EORTC scale Standard Deviation 23.46	4.4 Points on EORTC scale Standard Deviation 12.88
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 109 (n= 44, 39, 14)	8.3 Points on EORTC scale Standard Deviation 17.33	4.1 Points on EORTC scale Standard Deviation 22.61	12.5 Points on EORTC scale Standard Deviation 11.20
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 115 (n= 44, 36, 17)	8.1 Points on EORTC scale Standard Deviation 21.15	6.0 Points on EORTC scale Standard Deviation 21.23	10.3 Points on EORTC scale Standard Deviation 10.84
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 121 (n= 44, 39, 16)	8.3 Points on EORTC scale Standard Deviation 20.01	4.5 Points on EORTC scale Standard Deviation 21.36	9.4 Points on EORTC scale Standard Deviation 7.98
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 127 (n= 47, 36, 17)	10.6 Points on EORTC scale Standard Deviation 17.61	7.2 Points on EORTC scale Standard Deviation 21.19	8.3 Points on EORTC scale Standard Deviation 13.50
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 133 (n= 29, 31, 11)	7.5 Points on EORTC scale Standard Deviation 19.46	8.3 Points on EORTC scale Standard Deviation 19.48	9.1 Points on EORTC scale Standard Deviation 7.87
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 139 (n= 20, 19, 6)	9.6 Points on EORTC scale Standard Deviation 11.87	9.2 Points on EORTC scale Standard Deviation 16.87	11.1 Points on EORTC scale Standard Deviation 10.09
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 157 (n= 1, 3, 0)	16.7 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed	-11.1 Points on EORTC scale Standard Deviation 17.35	—
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 7 (n= 239, 183, 218)	4.0 Points on EORTC scale Standard Deviation 16.82	2.0 Points on EORTC scale Standard Deviation 18.10	3.1 Points on EORTC scale Standard Deviation 17.39
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 11 (n= 201, 112, 163)	5.3 Points on EORTC scale Standard Deviation 14.84	3.7 Points on EORTC scale Standard Deviation 15.57	2.0 Points on EORTC scale Standard Deviation 18.89
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 13 (n= 195, 106, 130)	3.8 Points on EORTC scale Standard Deviation 15.99	4.3 Points on EORTC scale Standard Deviation 17.53	2.9 Points on EORTC scale Standard Deviation 18.03
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 17 (n= 158, 84, 104)	5.6 Points on EORTC scale Standard Deviation 16.54	4.2 Points on EORTC scale Standard Deviation 18.81	4.9 Points on EORTC scale Standard Deviation 15.86
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning Week 19 (n= 164, 96, 98)	5.8 Points on EORTC scale Standard Deviation 16.26	6.2 Points on EORTC scale Standard Deviation 19.01	6.5 Points on EORTC scale Standard Deviation 18.27

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.

Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 7 (n= 239, 183, 218)	-3.6 Points on EORTC scale Standard Deviation 24.21	-11.6 Points on EORTC scale Standard Deviation 28.25	-4.9 Points on EORTC scale Standard Deviation 22.44
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 13 (n= 195, 106, 130)	-3.1 Points on EORTC scale Standard Deviation 24.15	-8.3 Points on EORTC scale Standard Deviation 25.33	-6.9 Points on EORTC scale Standard Deviation 25.65
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 19 (n= 164, 96, 98)	-1.3 Points on EORTC scale Standard Deviation 24.56	-4.3 Points on EORTC scale Standard Deviation 25.04	-6.1 Points on EORTC scale Standard Deviation 24.80
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 23 (n= 134, 86, 75)	-2.6 Points on EORTC scale Standard Deviation 25.76	-6.4 Points on EORTC scale Standard Deviation 24.14	-8.4 Points on EORTC scale Standard Deviation 24.56
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 49 (n= 97, 70, 40)	1.7 Points on EORTC scale Standard Deviation 20.62	-1.2 Points on EORTC scale Standard Deviation 21.67	-2.1 Points on EORTC scale Standard Deviation 21.08
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 5 (n= 233, 183, 221)	-4.1 Points on EORTC scale Standard Deviation 23.71	-6.8 Points on EORTC scale Standard Deviation 24.90	-4.4 Points on EORTC scale Standard Deviation 21.18
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 97 (n= 58, 49, 17)	0.6 Points on EORTC scale Standard Deviation 23.77	-7.5 Points on EORTC scale Standard Deviation 26.80	0.0 Points on EORTC scale Standard Deviation 13.18
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 103 (n= 53, 46, 17)	-0.6 Points on EORTC scale Standard Deviation 26.95	-9.8 Points on EORTC scale Standard Deviation 23.46	2.0 Points on EORTC scale Standard Deviation 10.00
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 109 (n= 44, 39, 14)	1.1 Points on EORTC scale Standard Deviation 21.98	-5.6 Points on EORTC scale Standard Deviation 22.73	4.8 Points on EORTC scale Standard Deviation 10.19
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 115 (n= 44, 36, 17)	1.1 Points on EORTC scale Standard Deviation 22.27	-10.6 Points on EORTC scale Standard Deviation 28.77	2.0 Points on EORTC scale Standard Deviation 11.61
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 121 (n= 44, 39, 16)	0.4 Points on EORTC scale Standard Deviation 28.41	-8.1 Points on EORTC scale Standard Deviation 26.73	2.1 Points on EORTC scale Standard Deviation 14.75
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 127 (n= 47, 36, 17)	1.4 Points on EORTC scale Standard Deviation 24.03	-6.0 Points on EORTC scale Standard Deviation 26.17	1.0 Points on EORTC scale Standard Deviation 7.15
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 133 (n= 29, 31, 11)	1.1 Points on EORTC scale Standard Deviation 34.48	-4.3 Points on EORTC scale Standard Deviation 24.33	-1.5 Points on EORTC scale Standard Deviation 11.68
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 139 (n= 20, 19, 6)	-5.8 Points on EORTC scale Standard Deviation 9.79	-8.8 Points on EORTC scale Standard Deviation 18.73	8.3 Points on EORTC scale Standard Deviation 13.94
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 145 (n= 14, 14, 6)	-6.0 Points on EORTC scale Standard Deviation 34.96	-10.7 Points on EORTC scale Standard Deviation 16.80	0.0 Points on EORTC scale Standard Deviation 23.57
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 151 (n= 7, 7, 1)	7.1 Points on EORTC scale Standard Deviation 26.97	-14.3 Points on EORTC scale Standard Deviation 17.82	0.0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 157 (n= 1, 3, 0)	0.0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed	-11.1 Points on EORTC scale Standard Deviation 19.25	—
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 11 (n= 201, 112, 163)	-3.2 Points on EORTC scale Standard Deviation 24.46	-9.7 Points on EORTC scale Standard Deviation 28.97	-6.1 Points on EORTC scale Standard Deviation 24.56
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 17 (n= 158, 84, 104)	-3.2 Points on EORTC scale Standard Deviation 26.14	-11.1 Points on EORTC scale Standard Deviation 27.05	-6.3 Points on EORTC scale Standard Deviation 20.27
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 25 (n= 144, 97, 75)	0.7 Points on EORTC scale Standard Deviation 21.13	-7.7 Points on EORTC scale Standard Deviation 23.70	-7.8 Points on EORTC scale Standard Deviation 23.78
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 31 (n= 123, 92, 51)	-0.7 Points on EORTC scale Standard Deviation 21.38	-3.1 Points on EORTC scale Standard Deviation 24.82	-3.9 Points on EORTC scale Standard Deviation 23.24
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 37 (n= 116, 88, 48)	1.6 Points on EORTC scale Standard Deviation 22.94	-3.2 Points on EORTC scale Standard Deviation 26.37	-3.1 Points on EORTC scale Standard Deviation 21.92
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 43 (n= 103, 74, 44)	1.0 Points on EORTC scale Standard Deviation 20.85	-3.4 Points on EORTC scale Standard Deviation 26.46	-1.1 Points on EORTC scale Standard Deviation 19.49
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 55 (n= 86, 66, 34)	1.6 Points on EORTC scale Standard Deviation 20.07	-4.8 Points on EORTC scale Standard Deviation 21.03	1.0 Points on EORTC scale Standard Deviation 16.89
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 61 (n= 85, 61, 31)	0.4 Points on EORTC scale Standard Deviation 19.58	-3.0 Points on EORTC scale Standard Deviation 24.82	1.1 Points on EORTC scale Standard Deviation 21.05
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 67 (n= 76, 61, 29)	0.7 Points on EORTC scale Standard Deviation 19.33	-4.6 Points on EORTC scale Standard Deviation 25.84	-1.7 Points on EORTC scale Standard Deviation 17.45
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 73 (n= 67, 54, 19)	0.5 Points on EORTC scale Standard Deviation 19.24	-5.6 Points on EORTC scale Standard Deviation 26.70	-0.9 Points on EORTC scale Standard Deviation 17.10
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 79 (n= 67, 54, 21)	-0.7 Points on EORTC scale Standard Deviation 18.45	-8.3 Points on EORTC scale Standard Deviation 27.99	-2.4 Points on EORTC scale Standard Deviation 12.12
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 85 (n= 68, 51, 18)	-2.2 Points on EORTC scale Standard Deviation 16.26	-9.8 Points on EORTC scale Standard Deviation 28.90	0.9 Points on EORTC scale Standard Deviation 12.09
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning Week 91 (n= 62, 53, 16)	1.1 Points on EORTC scale Standard Deviation 22.76	-10.7 Points on EORTC scale Standard Deviation 29.25	2.1 Points on EORTC scale Standard Deviation 13.44

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157

Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.

Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.

Outcome measures

Measure	Nivolumab n=316 Participants Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=314 Participants Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=315 Participants Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 17 (n= 158, 84, 104)	-1.4 Points on EORTC scale Standard Deviation 15.82	-6.7 Points on EORTC scale Standard Deviation 17.27	-3.7 Points on EORTC scale Standard Deviation 13.46
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 25 (n= 144, 97, 75)	1.4 Points on EORTC scale Standard Deviation 11.02	-4.2 Points on EORTC scale Standard Deviation 14.28	-3.6 Points on EORTC scale Standard Deviation 16.19
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 55 (n= 86, 66, 34)	1.8 Points on EORTC scale Standard Deviation 11.68	-2.9 Points on EORTC scale Standard Deviation 13.24	0.2 Points on EORTC scale Standard Deviation 10.57
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 67 (n= 76, 61, 29)	0.9 Points on EORTC scale Standard Deviation 12.44	-1.7 Points on EORTC scale Standard Deviation 13.22	-3.9 Points on EORTC scale Standard Deviation 10.62
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 127 (n= 47, 36, 17)	1.2 Points on EORTC scale Standard Deviation 17.21	-3.0 Points on EORTC scale Standard Deviation 16.75	-2.4 Points on EORTC scale Standard Deviation 5.75
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 145 (n= 14, 14, 6)	-1.4 Points on EORTC scale Standard Deviation 27.94	-6.7 Points on EORTC scale Standard Deviation 9.06	-6.7 Points on EORTC scale Standard Deviation 8.43
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 151 (n= 7, 7, 1)	8.6 Points on EORTC scale Standard Deviation 17.52	-9.5 Points on EORTC scale Standard Deviation 12.68	0.0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 43 (n= 103, 74, 44)	1.9 Points on EORTC scale Standard Deviation 13.16	-0.5 Points on EORTC scale Standard Deviation 13.55	-1.7 Points on EORTC scale Standard Deviation 12.71
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 5 (n= 233, 183, 221)	-2.6 Points on EORTC scale Standard Deviation 13.62	-4.9 Points on EORTC scale Standard Deviation 14.52	-5.2 Points on EORTC scale Standard Deviation 14.09
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 7 (n= 239, 183, 218)	-2.4 Points on EORTC scale Standard Deviation 14.53	-5.3 Points on EORTC scale Standard Deviation 14.92	-5.1 Points on EORTC scale Standard Deviation 14.69
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 11 (n= 201, 112, 163)	-2.4 Points on EORTC scale Standard Deviation 16.14	-5.6 Points on EORTC scale Standard Deviation 13.76	-6.3 Points on EORTC scale Standard Deviation 14.72
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 13 (n= 195, 106, 130)	-1.7 Points on EORTC scale Standard Deviation 15.79	-4.3 Points on EORTC scale Standard Deviation 14.11	-5.0 Points on EORTC scale Standard Deviation 17.47
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 19 (n= 164, 96, 98)	0.4 Points on EORTC scale Standard Deviation 14.14	-3.7 Points on EORTC scale Standard Deviation 14.34	-4.3 Points on EORTC scale Standard Deviation 17.70
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 23 (n= 134, 86, 75)	0.9 Points on EORTC scale Standard Deviation 13.87	-4.0 Points on EORTC scale Standard Deviation 15.59	-5.5 Points on EORTC scale Standard Deviation 15.04
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 31 (n= 123, 92, 51)	1.9 Points on EORTC scale Standard Deviation 11.60	-2.4 Points on EORTC scale Standard Deviation 12.91	-2.9 Points on EORTC scale Standard Deviation 14.62
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 37 (n= 116, 88, 48)	2.1 Points on EORTC scale Standard Deviation 13.57	-0.8 Points on EORTC scale Standard Deviation 13.00	-2.2 Points on EORTC scale Standard Deviation 13.71
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 49 (n= 97, 70, 40)	1.3 Points on EORTC scale Standard Deviation 12.08	-0.1 Points on EORTC scale Standard Deviation 12.97	0.2 Points on EORTC scale Standard Deviation 12.31
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 61 (n= 85, 61, 31)	0.2 Points on EORTC scale Standard Deviation 11.65	-2.1 Points on EORTC scale Standard Deviation 13.91	-0.2 Points on EORTC scale Standard Deviation 11.35
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 73 (n= 67, 54, 19)	0.5 Points on EORTC scale Standard Deviation 14.38	-3.5 Points on EORTC scale Standard Deviation 11.27	-3.9 Points on EORTC scale Standard Deviation 7.80
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 79 (n= 67, 54, 21)	-1.7 Points on EORTC scale Standard Deviation 7.99	-4.3 Points on EORTC scale Standard Deviation 17.09	-1.3 Points on EORTC scale Standard Deviation 6.54
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 85 (n= 68, 51, 18)	-1.6 Points on EORTC scale Standard Deviation 12.86	-3.5 Points on EORTC scale Standard Deviation 12.88	-2.6 Points on EORTC scale Standard Deviation 6.11
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 91 (n= 62, 53, 16)	-0.4 Points on EORTC scale Standard Deviation 13.27	-4.2 Points on EORTC scale Standard Deviation 14.45	0.0 Points on EORTC scale Standard Deviation 0.00
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 97 (n= 58, 49, 17)	-0.4 Points on EORTC scale Standard Deviation 13.79	-4.4 Points on EORTC scale Standard Deviation 16.53	-0.8 Points on EORTC scale Standard Deviation 4.00
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 103 (n= 53, 46, 17)	-1.5 Points on EORTC scale Standard Deviation 17.18	-5.4 Points on EORTC scale Standard Deviation 15.63	-2.4 Points on EORTC scale Standard Deviation 7.05
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 109 (n= 44, 39, 14)	1.7 Points on EORTC scale Standard Deviation 14.74	-1.2 Points on EORTC scale Standard Deviation 13.92	-1.0 Points on EORTC scale Standard Deviation 3.56
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 115 (n= 44, 36, 17)	0.2 Points on EORTC scale Standard Deviation 14.20	-2.0 Points on EORTC scale Standard Deviation 15.10	-0.8 Points on EORTC scale Standard Deviation 3.23
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 121 (n= 44, 39, 16)	-0.3 Points on EORTC scale Standard Deviation 15.77	-3.4 Points on EORTC scale Standard Deviation 13.58	-2.5 Points on EORTC scale Standard Deviation 5.37
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 133 (n= 29, 31, 11)	0.2 Points on EORTC scale Standard Deviation 23.33	0.4 Points on EORTC scale Standard Deviation 14.40	-2.4 Points on EORTC scale Standard Deviation 6.16
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 139 (n= 20, 19, 6)	0.4 Points on EORTC scale Standard Deviation 7.94	-3.9 Points on EORTC scale Standard Deviation 11.40	-3.3 Points on EORTC scale Standard Deviation 5.58
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning Week 157 (n= 1, 3, 0)	0.0 Points on EORTC scale Standard Deviation NA No SD calculated; only one patient analyzed	-17.8 Points on EORTC scale Standard Deviation 25.24	—

Adverse Events

Nivolumab

Serious events: 187 serious events

Other events: 302 other events

Deaths: 192 deaths

Nivolumab + Ipilimumab

Serious events: 249 serious events

Other events: 302 other events

Deaths: 173 deaths

Ipilimumab

Serious events: 205 serious events

Other events: 302 other events

Deaths: 243 deaths

Serious adverse events

Measure	Nivolumab n=313 participants at risk Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=313 participants at risk Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=311 participants at risk Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Blood and lymphatic system disorders Anaemia	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Bicytopenia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Desmoid tumour	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Lymphadenopathy	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Neutropenia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Blood and lymphatic system disorders Thrombocytopenia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Acute coronary syndrome	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Arrhythmia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Atrial fibrillation	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Atrial flutter	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Atrioventricular block	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Bradycardia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cardiac arrest	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cardiac failure	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cardiac failure chronic	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cardiac failure congestive	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cardiac tamponade	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cardiomyopathy	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Cor pulmonale	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Coronary artery disease	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Myocardial infarction	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Pericardial effusion	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Sinus tachycardia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Ear and labyrinth disorders Vertigo	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Adrenal haemorrhage	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Adrenal insufficiency	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Endocrine disorder	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Glucocorticoid deficiency	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Goitre	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hyperparathyroidism	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hyperthyroidism	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hypophysitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hypopituitarism	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hypothyroidism	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Lymphocytic hypophysitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Secondary adrenocortical insufficiency	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Thyroiditis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Eye disorders Diplopia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Eye disorders Eye haemorrhage	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Eye disorders Uveitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Abdominal distension	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Abdominal pain	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.3% 7/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Anal fistula	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Ascites	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Autoimmune colitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Autoimmune pancreatitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Chronic gastritis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Colitis	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	10.5% 33/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.3% 29/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Constipation	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Diarrhoea	2.6% 8/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	12.8% 40/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.4% 26/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Dysphagia	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Enteritis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Enterocolitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Gastric haemorrhage	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Gastritis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Gastrointestinal disorder	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Haematochezia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Ileus paralytic	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Intestinal perforation	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Intussusception	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Large intestine perforation	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Lymphangiectasia intestinal	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Nausea	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Oesophageal pain	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Pancreatitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Rectal prolapse	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Small intestinal obstruction	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Subileus	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Volvulus	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Vomiting	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.5% 11/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Accidental death	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Asthenia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Catheter site discharge	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Chest pain	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Chills	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Death	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Fatigue	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders General physical health deterioration	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.2% 10/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Hyperthermia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Inflammation	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Influenza like illness	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Malaise	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Mucosal inflammation	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Multiple organ dysfunction syndrome	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Nodule	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Non-cardiac chest pain	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Pain	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Performance status decreased	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Pyrexia	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.6% 30/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.9% 12/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Sudden cardiac death	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Sudden death	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Systemic inflammatory response syndrome	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Autoimmune hepatitis	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Biliary obstruction	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Cholecystitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Cholecystitis acute	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Cholelithiasis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Hepatic cytolysis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Hepatitis	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Hepatitis acute	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Hepatomegaly	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Hepatorenal failure	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Hypertransaminasaemia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Immune-mediated hepatitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Hepatobiliary disorders Portal hypertension	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Immune system disorders Anaphylactic shock	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Abscess intestinal	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Anal abscess	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Appendicitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Bacteraemia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Biliary sepsis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Bronchitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Bursitis infective	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Cellulitis	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Citrobacter sepsis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Clostridium bacteraemia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Clostridium difficile colitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Clostridium difficile infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Device related infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Diverticulitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Diverticulitis intestinal perforated	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Encephalitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Enterococcal sepsis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Erysipelas	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Escherichia sepsis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Febrile infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Folliculitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Gastroenteritis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Gastroenteritis viral	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Gastrointestinal infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Groin abscess	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations H1N1 influenza	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Herpes zoster	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Infection	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Localised infection	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Lower respiratory tract infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Meningitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Oral candidiasis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Peritonitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Peritonitis bacterial	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Pneumococcal sepsis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Pneumocystis jirovecii pneumonia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Pneumonia	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Pneumonia streptococcal	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Postoperative wound infection	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Pyelonephritis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Respiratory tract infection	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Sepsis	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Septic shock	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Staphylococcal infection	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Streptococcal infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Tonsillitis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Urinary tract infection	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Urosepsis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Viral infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Wound infection	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Concussion	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Fall	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Femur fracture	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Multiple fractures	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Osteoradionecrosis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Post procedural complication	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Radius fracture	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Spinal fracture	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Tibia fracture	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Injury, poisoning and procedural complications Urinary retention postoperative	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Alanine aminotransferase increased	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Aspartate aminotransferase increased	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Blood creatine phosphokinase increased	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Cortisol decreased	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Electrocardiogram QT prolonged	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Gamma-glutamyltransferase increased	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations General physical condition abnormal	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Hepatic enzyme increased	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Lipase increased	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Liver function test increased	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Transaminases increased	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Weight decreased	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Dehydration	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.2% 10/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Diabetes mellitus	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hyperglycaemia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hypocalcaemia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hypokalaemia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Steroid diabetes	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Back pain	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Groin pain	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Muscular weakness	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Myalgia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Pathological fracture	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Polymyositis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoid cystic carcinoma of salivary gland	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	2.6% 8/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected metastasis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal metastasis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	17.3% 54/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	12.1% 38/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	19.6% 61/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	2.9% 9/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Ataxia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Cerebral haemorrhage	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Cerebrovascular accident	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Diabetic coma	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Encephalopathy	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Epilepsy	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Facial paralysis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Haemorrhage intracranial	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Haemorrhagic stroke	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Headache	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Hemiparesis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Hydrocephalus	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Intracranial tumour haemorrhage	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Intraventricular haemorrhage	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Ischaemic stroke	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Lethargy	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Medullary compression syndrome	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Nerve compression	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Nervous system disorder	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Neuralgia	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Neuropathy peripheral	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Paraparesis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Peripheral motor neuropathy	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Polyneuropathy	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Seizure	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Sensory disturbance	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Somnolence	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Spinal claudication	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Spinal cord compression	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Subarachnoid haemorrhage	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Syncope	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Transient ischaemic attack	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Product Issues Device breakage	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Product Issues Device loosening	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Product Issues Device malfunction	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Anxiety	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Confusional state	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Delirium	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Delusion	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Mental status changes	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Psychotic disorder	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Acute kidney injury	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.2% 10/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Autoimmune nephritis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Dysuria	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Glomerulonephritis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Immune-mediated nephritis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Lower urinary tract symptoms	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Nephrolithiasis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Nephropathy toxic	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Prerenal failure	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Renal colic	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Renal failure	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Renal impairment	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Renal mass	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Renal and urinary disorders Urinary retention	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Reproductive system and breast disorders Ejaculation failure	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Reproductive system and breast disorders Prostatitis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Cough	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Hepatic hydrothorax	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Malignant pleural effusion	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.5% 11/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Dermatomyositis	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Rash	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Rash pruritic	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Skin oedema	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Vasculitic ulcer	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Arteriosclerosis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Deep vein thrombosis	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Embolism	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Haematoma	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Hypertension	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Hypotension	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Inferior vena caval occlusion	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Lymphorrhoea	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Orthostatic hypotension	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Superior vena cava syndrome	0.00% 0/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.00% 0/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.

Other adverse events

Measure	Nivolumab n=313 participants at risk Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity	Nivolumab + Ipilimumab n=313 participants at risk Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity	Ipilimumab n=311 participants at risk Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
Blood and lymphatic system disorders Anaemia	11.2% 35/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.1% 41/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.8% 43/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Cardiac disorders Tachycardia	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.2% 13/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Adrenal insufficiency	1.3% 4/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.3% 7/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hyperthyroidism	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.6% 30/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.96% 3/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hypophysitis	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.4% 20/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Endocrine disorders Hypothyroidism	12.1% 38/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	21.7% 68/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Eye disorders Dry eye	5.4% 17/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.8% 12/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Eye disorders Vision blurred	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.8% 15/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Abdominal distension	5.4% 17/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.2% 13/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Abdominal pain	19.8% 62/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	18.8% 59/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	21.9% 68/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Abdominal pain upper	7.7% 24/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.7% 24/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.0% 25/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Colitis	2.9% 9/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.7% 21/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.8% 15/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Constipation	22.0% 69/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	20.1% 63/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	24.8% 77/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Diarrhoea	39.0% 122/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	53.7% 168/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	47.3% 147/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Dry mouth	8.9% 28/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	10.9% 34/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Dyspepsia	5.4% 17/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.8% 12/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.5% 14/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.1% 19/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.2% 13/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.5% 14/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Nausea	33.5% 105/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	43.5% 136/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	33.4% 104/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Gastrointestinal disorders Vomiting	22.0% 69/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	31.6% 99/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	19.3% 60/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Asthenia	15.0% 47/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	16.0% 50/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.3% 29/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Chest pain	6.1% 19/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.8% 12/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.2% 13/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Chills	7.3% 23/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	11.2% 35/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.4% 20/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Fatigue	50.8% 159/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	53.7% 168/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	45.0% 140/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Influenza like illness	9.9% 31/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.9% 28/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.0% 25/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Oedema peripheral	12.5% 39/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	12.5% 39/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	14.5% 45/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Pain	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.3% 23/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.3% 29/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
General disorders Pyrexia	20.4% 64/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	39.3% 123/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	19.6% 61/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Conjunctivitis	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.1% 19/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.9% 6/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Influenza	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.4% 20/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Nasopharyngitis	13.7% 43/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	10.9% 34/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.3% 29/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Rhinitis	6.4% 20/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.3% 26/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.2% 10/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Sinusitis	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.5% 14/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Upper respiratory tract infection	10.2% 32/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.9% 28/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Infections and infestations Urinary tract infection	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.3% 23/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Alanine aminotransferase increased	8.0% 25/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	22.0% 69/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.8% 18/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Amylase increased	7.3% 23/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	10.5% 33/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Aspartate aminotransferase increased	8.0% 25/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	19.5% 61/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.1% 19/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Blood alkaline phosphatase increased	4.5% 14/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.1% 19/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Blood creatinine increased	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.0% 25/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.8% 15/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Gamma-glutamyltransferase increased	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.2% 10/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Lipase increased	11.2% 35/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	16.3% 51/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.8% 21/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Investigations Weight decreased	8.9% 28/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.4% 42/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.4% 26/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Decreased appetite	24.3% 76/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	31.0% 97/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	24.4% 76/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Dehydration	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.7% 24/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hyperglycaemia	2.9% 9/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hypoalbuminaemia	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hypokalaemia	3.8% 12/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	11.8% 37/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.8% 15/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Metabolism and nutrition disorders Hyponatraemia	2.2% 7/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.0% 25/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.5% 14/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Arthralgia	27.8% 87/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	25.2% 79/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	25.1% 78/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Back pain	18.5% 58/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	14.7% 46/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	17.0% 53/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Groin pain	5.4% 17/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	1.6% 5/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Muscle spasms	7.0% 22/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Muscular weakness	4.2% 13/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.0% 22/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.9% 12/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.2% 13/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Myalgia	10.9% 34/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	10.5% 33/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.4% 23/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Neck pain	4.8% 15/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.9% 12/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	15.7% 49/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	12.1% 38/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.8% 43/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Dizziness	10.5% 33/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.7% 43/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.6% 30/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Dysgeusia	5.4% 17/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Headache	25.2% 79/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	26.2% 82/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	25.1% 78/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Nervous system disorders Paraesthesia	7.3% 23/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.8% 18/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Anxiety	3.5% 11/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.7% 24/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.1% 19/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Depression	3.8% 12/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.7% 21/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Psychiatric disorders Insomnia	14.1% 44/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	16.3% 51/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.5% 42/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Cough	31.9% 100/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	26.2% 82/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	22.2% 69/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.0% 47/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	23.0% 72/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.8% 43/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	6.4% 20/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.5% 14/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.7% 21/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.8% 15/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.6% 8/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.4% 20/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.3% 23/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.9% 6/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.4% 17/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.3% 7/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Actinic keratosis	5.4% 17/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.64% 2/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	0.32% 1/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Dry skin	8.9% 28/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.6% 30/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	6.1% 19/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Erythema	8.0% 25/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.1% 16/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	4.5% 14/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.8% 12/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	7.0% 22/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.5% 11/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Pruritus	29.4% 92/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	40.3% 126/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	43.4% 135/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Rash	32.3% 101/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	35.5% 111/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	27.0% 84/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.0% 22/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	14.1% 44/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	13.8% 43/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Skin lesion	6.4% 20/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	3.5% 11/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	2.9% 9/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Skin and subcutaneous tissue disorders Vitiligo	12.1% 38/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	9.3% 29/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	5.5% 17/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
Vascular disorders Hypertension	10.9% 34/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.3% 26/313 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.	8.7% 27/311 • All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months). All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
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Restriction type: OTHER