Trial Outcomes & Findings for A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin (NCT NCT03143153)

Last Updated: 2026-02-17

Results Overview

Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

970 participants

Primary outcome timeframe

From the date of randomization to up to the date of death (up to approximately 20 months)

Results posted on

2026-02-17

Participant Flow

970 participants randomized, 936 treated.

Participant milestones

Participant milestones
Measure	Arm A: Nivolumab + Ipilimumab Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Pre-Treatment STARTED	325	321	324
Pre-Treatment COMPLETED	322	310	304
Pre-Treatment NOT COMPLETED	3	11	20
Treatment STARTED	322	310	304
Treatment COMPLETED	0	0	0
Treatment NOT COMPLETED	322	310	304

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Nivolumab + Ipilimumab Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Pre-Treatment Participant request to discontinue study treatment	0	0	2
Pre-Treatment Participant withdrew consent	0	1	12
Pre-Treatment Participant no longer meets study criteria	0	4	2
Pre-Treatment Other Reasons	1	2	1
Pre-Treatment Disease Progression	1	1	2
Pre-Treatment Adverse event unrelated to study drug	1	3	1
Treatment Disease progression	182	191	199
Treatment Study drug toxicity	59	36	38
Treatment Death	6	4	4
Treatment Adverse event unrelated to study drug	19	26	11
Treatment Participant request to discontinue study treatment	13	22	21
Treatment Participant withdrew consent	3	4	12
Treatment Pregnancy	1	0	0
Treatment Maximum clinical benefit	1	3	4
Treatment Completed treatment as per Protocol	28	14	0
Treatment Other reasons	10	10	15

Baseline Characteristics

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Nivolumab + Ipilimumab n=325 Participants Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy n=321 Participants Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy n=324 Participants Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Total n=970 Participants Total of all reporting groups
Age, Continuous	62.2 Years STANDARD_DEVIATION 9.1 • n=25 Participants	63.1 Years STANDARD_DEVIATION 9.2 • n=20 Participants	63.3 Years STANDARD_DEVIATION 8.7 • n=45 Participants	62.9 Years STANDARD_DEVIATION 9.0 • n=76 Participants
Sex: Female, Male Female	56 Participants n=25 Participants	68 Participants n=20 Participants	49 Participants n=45 Participants	173 Participants n=76 Participants
Sex: Female, Male Male	269 Participants n=25 Participants	253 Participants n=20 Participants	275 Participants n=45 Participants	797 Participants n=76 Participants
Race/Ethnicity, Customized White	79 Participants n=25 Participants	85 Participants n=20 Participants	84 Participants n=45 Participants	248 Participants n=76 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=25 Participants	1 Participants n=20 Participants	6 Participants n=45 Participants	11 Participants n=76 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=25 Participants	2 Participants n=20 Participants	1 Participants n=45 Participants	4 Participants n=76 Participants
Race/Ethnicity, Customized Asian Indian	1 Participants n=25 Participants	4 Participants n=20 Participants	3 Participants n=45 Participants	8 Participants n=76 Participants
Race/Ethnicity, Customized Chinese	71 Participants n=25 Participants	74 Participants n=20 Participants	70 Participants n=45 Participants	215 Participants n=76 Participants
Race/Ethnicity, Customized Japanese	131 Participants n=25 Participants	126 Participants n=20 Participants	137 Participants n=45 Participants	394 Participants n=76 Participants
Race/Ethnicity, Customized Asian Other	28 Participants n=25 Participants	23 Participants n=20 Participants	17 Participants n=45 Participants	68 Participants n=76 Participants
Race/Ethnicity, Customized Other	10 Participants n=25 Participants	6 Participants n=20 Participants	6 Participants n=45 Participants	22 Participants n=76 Participants

PRIMARY outcome

Timeframe: From the date of randomization to up to the date of death (up to approximately 20 months)

Population: All randomized PD-L1 expressing participants

Outcome measures

Outcome measures
Measure	Arm A: Nivolumab + Ipilimumab n=158 Participants Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy n=158 Participants Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy n=157 Participants Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Overall Survival (OS) in Participants With Tumor Cell PD-L1	13.70 Months Interval 11.24 to 17.02	15.44 Months Interval 11.93 to 19.52	9.07 Months Interval 7.69 to 9.95

PRIMARY outcome

Timeframe: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)

Population: All randomized PD-L1 expressing participants

Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.

Outcome measures

Outcome measures
Measure	Arm A: Nivolumab + Ipilimumab n=158 Participants Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy n=158 Participants Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy n=157 Participants Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	4.04 Months Interval 2.4 to 4.93	6.93 Months Interval 5.68 to 8.34	4.44 Months Interval 2.89 to 5.82

SECONDARY outcome

Timeframe: From the date of randomization to up to the date of death (up to approximately 88 months)

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Arm A: Nivolumab + Ipilimumab n=325 Participants Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy n=321 Participants Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy n=324 Participants Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Overall Survival (OS) in All Randomized Participants	12.747 Months Interval 11.269 to 15.474	13.207 Months Interval 11.105 to 15.671	10.710 Months Interval 9.396 to 12.09

SECONDARY outcome

Timeframe: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 88 months)

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Arm A: Nivolumab + Ipilimumab n=325 Participants Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy n=321 Participants Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy n=324 Participants Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR	2.891 Months Interval 2.661 to 4.172	5.782 Months Interval 5.52 to 6.998	5.618 Months Interval 4.304 to 5.914

SECONDARY outcome

Timeframe: From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)

Population: All randomized PD-L1 expressing participants and all randomized participants

Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.

Outcome measures

Outcome measures
Measure	Arm A: Nivolumab + Ipilimumab n=325 Participants Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy n=321 Participants Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy n=324 Participants Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Objective Response Rate (ORR) as Assessed by BICR Participants with baseline PD-L1 status >= 1%	35.4 Percentage of participants Interval 28.0 to 43.4	53.2 Percentage of participants Interval 45.1 to 61.1	19.9 Percentage of participants Interval 13.9 to 27.0
Objective Response Rate (ORR) as Assessed by BICR Participants with baseline PD-L1 status < 5%	22.3 Percentage of participants Interval 16.7 to 28.6	44.8 Percentage of participants Interval 37.8 to 51.9	30.9 Percentage of participants Interval 24.7 to 37.7
Objective Response Rate (ORR) as Assessed by BICR Participants with baseline PD-L1 status >= 5%	36.7 Percentage of participants Interval 28.1 to 45.9	51.7 Percentage of participants Interval 42.4 to 60.9	20.0 Percentage of participants Interval 13.1 to 28.5
Objective Response Rate (ORR) as Assessed by BICR Participants with baseline PD-L1 status < 10%	23.3 Percentage of participants Interval 17.9 to 29.5	46.1 Percentage of participants Interval 39.4 to 53.0	29.3 Percentage of participants Interval 23.5 to 35.8
Objective Response Rate (ORR) as Assessed by BICR Participants with baseline PD-L1 status >= 10%	36.9 Percentage of participants Interval 27.6 to 47.0	50.0 Percentage of participants Interval 39.9 to 60.1	21.6 Percentage of participants Interval 13.9 to 31.2
Objective Response Rate (ORR) as Assessed by BICR Participants with baseline PD-L1 status < 1%	20.1 Percentage of participants Interval 14.3 to 27.1	41.7 Percentage of participants Interval 34.1 to 49.7	33.7 Percentage of participants Interval 26.6 to 41.5
Objective Response Rate (ORR) as Assessed by BICR Participants with baseline PD-L1 status indeterminate, not evaluable, or missing	33.3 Percentage of participants Interval 0.8 to 90.6	—	0.0 Percentage of participants Interval 0.0 to 84.2
Objective Response Rate (ORR) as Assessed by BICR All randomized participants	27.4 Percentage of participants Interval 22.6 to 32.6	47.4 Percentage of participants Interval 41.8 to 53.0	26.9 Percentage of participants Interval 22.1 to 32.0

Adverse Events

Arm A: Nivolumab + Ipilimumab

Serious events: 243 serious events

Other events: 301 other events

Deaths: 270 deaths

Arm B: Nivolumab + Chemotherapy

Serious events: 226 serious events

Other events: 307 other events

Deaths: 273 deaths

Arm C: Chemotherapy

Serious events: 174 serious events

Other events: 288 other events

Deaths: 286 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Arm A: Nivolumab + Ipilimumab n=322 participants at risk Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.	Arm B: Nivolumab + Chemotherapy n=310 participants at risk Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.	Arm C: Chemotherapy n=304 participants at risk Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
Eye disorders Uveitis	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Anaemia	1.9% 6/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	1.6% 5/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	2.3% 7/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.62% 2/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Febrile neutropenia	1.9% 6/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	2.3% 7/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	1.6% 5/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Immune thrombocytopenia	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Leukocytosis	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Leukopenia	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Lymphadenopathy	0.62% 2/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.65% 2/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Splenic haematoma	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Acute myocardial infarction	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.66% 2/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Angina pectoris	0.62% 2/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Arrhythmia	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Arteriospasm coronary	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Atrial fibrillation	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.99% 3/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Cardiac arrest	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Cardiac failure congestive	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Myocardial infarction	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Palpitations	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Pericardial effusion	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Supraventricular tachycardia	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Cardiac disorders Ventricular fibrillation	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Adrenal insufficiency	2.5% 8/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.97% 3/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Endocrine disorder	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Hypercalcaemia of malignancy	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Hyperthyroidism	0.62% 2/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Hypophysitis	1.9% 6/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Hypopituitarism	2.2% 7/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Hypothyroidism	0.93% 3/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Secondary adrenocortical insufficiency	0.62% 2/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Endocrine disorders Thyroiditis	0.62% 2/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Eye disorders Cataract	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Eye disorders Eye pain	0.31% 1/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.00% 0/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
Eye disorders Retinal detachment	0.00% 0/322 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.32% 1/310 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.	0.33% 1/304 • All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months) All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.