Trial Outcomes & Findings for A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (NCT NCT05625399)
NCT ID: NCT05625399
Last Updated: 2026-08-26
Results Overview
Blood samples were collected to assess serum concentration.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
579 participants
Primary outcome timeframe
Pre-dose (Day 1 to Day 28)
Results posted on
2026-08-26
Participant Flow
Participant milestones
| Measure |
Nivo + Rela FDC SC
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Pre-Treatment
STARTED
|
286
|
292
|
|
Pre-Treatment
COMPLETED
|
283
|
291
|
|
Pre-Treatment
NOT COMPLETED
|
3
|
1
|
|
Treatment Period
STARTED
|
283
|
291
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
283
|
291
|
Reasons for withdrawal
| Measure |
Nivo + Rela FDC SC
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Pre-Treatment
Full withdrawal of consent by subject from study
|
1
|
0
|
|
Pre-Treatment
Subject no longer meets study criteria
|
2
|
1
|
|
Treatment Period
Other reasons
|
1
|
0
|
|
Treatment Period
Partial withdrawal of consent by subject
|
0
|
1
|
|
Treatment Period
Withdrawal of consent by subject from treatment period
|
3
|
4
|
|
Treatment Period
Full withdrawal of consent by subject from study
|
2
|
4
|
|
Treatment Period
Symptomatic deterioration
|
8
|
10
|
|
Treatment Period
Subject request to discontinue study treatment
|
0
|
1
|
|
Treatment Period
Progressive disease
|
108
|
93
|
|
Treatment Period
Adverse Event
|
49
|
68
|
|
Treatment Period
Ongoing treatment
|
112
|
110
|
Baseline Characteristics
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
Baseline characteristics by cohort
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
Total
n=578 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 13.60 • n=31 Participants
|
63.1 years
STANDARD_DEVIATION 13.58 • n=49 Participants
|
63.7 years
STANDARD_DEVIATION 13.59 • n=80 Participants
|
|
Age, Customized
18-64 years
|
130 Participants
n=31 Participants
|
147 Participants
n=49 Participants
|
277 Participants
n=80 Participants
|
|
Age, Customized
65-84 years
|
150 Participants
n=31 Participants
|
138 Participants
n=49 Participants
|
288 Participants
n=80 Participants
|
|
Age, Customized
85 years and over
|
6 Participants
n=31 Participants
|
7 Participants
n=49 Participants
|
13 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=31 Participants
|
120 Participants
n=49 Participants
|
229 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=31 Participants
|
172 Participants
n=49 Participants
|
349 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=31 Participants
|
65 Participants
n=49 Participants
|
123 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=31 Participants
|
209 Participants
n=49 Participants
|
402 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=31 Participants
|
18 Participants
n=49 Participants
|
53 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
White
|
239 Participants
n=31 Participants
|
264 Participants
n=49 Participants
|
503 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
4 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
40 Participants
n=31 Participants
|
19 Participants
n=49 Participants
|
59 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1 to Day 28)Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale
|
4.141 ug/mL
Standard Error 0.0167
|
3.901 ug/mL
Standard Error 0.0164
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1 to Day 28)Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale
|
3.120 ug/mL
Standard Error 0.0186
|
2.721 ug/mL
Standard Error 0.0183
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1 to Day 28)Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale
|
4.759 ug/mL
Standard Error 0.0335
|
4.169 ug/mL
Standard Error 0.0330
|
PRIMARY outcome
Timeframe: Pre-dose (Day 1 to Day 28)Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale
|
3.629 ug/mL
Standard Error 0.0525
|
2.631 ug/mL
Standard Error 0.0517
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Objective Response Rate (ORR) by BICR
|
43.0 percentage of participants
Interval 37.2 to 49.0
|
50.7 percentage of participants
Interval 44.8 to 56.6
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants
Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Disease Control Rate (ORR) Per BICR
|
62.2 percentage of participants
Interval 56.3 to 67.9
|
72.3 percentage of participants
Interval 66.7 to 77.3
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants
Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Time to Response (TTR) Per BICR
|
2.79 months
Interval 1.6 to 9.2
|
2.79 months
Interval 1.4 to 17.7
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants. Only responders are included in the analysis.
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis \< 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=123 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=148 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Duration of Response (DoR) Per BICR
|
NA months
Interval 1.5 to 20.4
Not estimated due to inadequate number of events
|
NA months
Interval 1.6 to 20.3
Not estimated due to inadequate number of events
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants.
Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Progression Free Survival Per BICR
|
12.65 months
Interval 8.08 to
Not applicable due to inadequate number of events.
|
14.98 months
Interval 12.12 to
Not applicable due to inadequate number of events.
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants
Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on Investigator assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Investigator
|
47.9 percentage of participants
Interval 42.0 to 53.9
|
52.4 percentage of participants
Interval 46.5 to 58.2
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants
Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on Investigator assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Disease Control Rate (ORR) Per Investigator
|
62.2 percentage of participants
Interval 56.3 to 67.9
|
72.3 percentage of participants
Interval 66.7 to 77.3
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants
Time to response (TTR) assessed by Investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Time to Response (TTR) Per Investigator
|
2.83 months
Interval 1.4 to 12.9
|
2.79 months
Interval 1.4 to 12.0
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants. Only responders are included in the analysis.
Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis \< 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=137 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=153 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Duration of Response (DoR) Per Investigator
|
NA months
Interval 1.5 to 20.4
Not estimated due to inadequate number of events
|
NA months
Interval 1.6 to 20.3
Not estimated due to inadequate number of events
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants.
Progression free survival (PFS) is defined as time from on treatment to disease progression or death (whichever comes first). At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Progression Free Survival Per Investigator
|
10.28 months
Interval 6.57 to 14.98
|
14.82 months
Interval 10.15 to
Not applicable due to inadequate number of events.
|
SECONDARY outcome
Timeframe: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 126 weeks)Population: All randomized participants.
Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause. Median computed using Kaplan-Meier method.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=286 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=292 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 21.09 to
Not estimated due to inadequate number of events.
|
NA months
Not estimated due to inadequate number of events.
|
SECONDARY outcome
Timeframe: Pre-dose at Day 28Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Trough Serum Concentration of Nivolumab and Relatlimab (Cmind28) at Day 28
Relatlimab
|
13.79 ug/mL
Geometric Coefficient of Variation 70
|
5.10 ug/mL
Geometric Coefficient of Variation 139
|
|
Trough Serum Concentration of Nivolumab and Relatlimab (Cmind28) at Day 28
Nivolumab
|
44.75 ug/mL
Geometric Coefficient of Variation 43
|
27.33 ug/mL
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Post-dose Day 1Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Peak Serum Concentration (Cmax1) After the First Dose of Nivolumab and Relatlimab
Relatlimab
|
32.62 ug/mL
Geometric Coefficient of Variation 36
|
46.70 ug/mL
Geometric Coefficient of Variation 20
|
|
Peak Serum Concentration (Cmax1) After the First Dose of Nivolumab and Relatlimab
Nivolumab
|
88.51 ug/mL
Geometric Coefficient of Variation 35
|
137.05 ug/mL
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Post-dose Day 1Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Maximum Observed Concentration at Steady State (Cmaxss) Nivolumab and Relatlimab
Relatlimab
|
71.58 ug/mL
Geometric Coefficient of Variation 44
|
65.42 ug/mL
Geometric Coefficient of Variation 29
|
|
Maximum Observed Concentration at Steady State (Cmaxss) Nivolumab and Relatlimab
Nivolumab
|
203.52 ug/mL
Geometric Coefficient of Variation 41
|
209.91 ug/mL
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Post-dose Day 1Population: PK Evaluable participants included all treated subjects with at least 1 post-treatment concentration-time data point available for nivo and rela.
Blood samples were collected to assess serum concentration.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Average Observed Concentration at Steady State (Cavgss) of Nivolumab and Relatlimab
Relatlimab
|
57.29 ug/mL
Geometric Coefficient of Variation 49
|
30.29 ug/mL
Geometric Coefficient of Variation 53
|
|
Average Observed Concentration at Steady State (Cavgss) of Nivolumab and Relatlimab
Nivolumab
|
164.02 ug/mL
Geometric Coefficient of Variation 44
|
106.33 ug/mL
Geometric Coefficient of Variation 39
|
SECONDARY outcome
Timeframe: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)Population: All treated participants
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths
Serious Adverse Events
|
109 Participants
|
112 Participants
|
|
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths
Death
|
11 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths
Adverse Events
|
275 Participants
|
285 Participants
|
|
Number of Participants With Adverse Events, SAEs, AEs Leading to Discontinuation and Deaths
AEs leading to Discontinuation
|
39 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: First dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months)Population: All treated participants
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Rash
|
25 Participants
|
21 Participants
|
|
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Pneumonitis
|
2 Participants
|
6 Participants
|
|
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Diarrhea/Colitis
|
17 Participants
|
12 Participants
|
|
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Hepatitis
|
16 Participants
|
11 Participants
|
|
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Nephritis/Renal Dysfunction
|
4 Participants
|
1 Participants
|
|
Number of Participants With Immune-mediate Adverse Events (IMAEs)
Hypersensitivity
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 28 months)Population: All treated participants
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Number of Participants With Other Event of Special Interest (OESI)
Immune mediated arthritis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Myasthenic syndrome
|
0 Participants
|
2 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Demyelination event
|
0 Participants
|
0 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Guillain-Barre syndrome
|
0 Participants
|
0 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Pancreatitis event
|
3 Participants
|
5 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Uveitis event
|
3 Participants
|
6 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Encephalitis event
|
3 Participants
|
4 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Myocarditis event
|
6 Participants
|
11 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Myositis/rhabdomyolysis event
|
5 Participants
|
2 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Graft Versus Host Disease
|
0 Participants
|
0 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Autoimmune cytopenia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Autoimmune eye disorder
|
0 Participants
|
0 Participants
|
|
Number of Participants With Other Event of Special Interest (OESI)
Other meningitis event
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 26 months)Population: All treated participants. Only participants with data were included in the analysis.
AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=272 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=283 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
CREATININE, LOCAL LAB
|
1 Participants
|
4 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HYPERNATREMIA
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HYPOCALCEMIA
|
1 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HEMOGLOBIN
|
12 Participants
|
10 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
PLATELET COUNT
|
2 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
LEUKOCYTES, LOCAL LAB
|
1 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
LYMPHOCYTES (ABSOLUTE), LOCAL LAB
|
5 Participants
|
7 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
NEUTROPHILS (ABSOLUTE), LOCAL LAB
|
3 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
ALKALINE PHOSPHATASE, LOCAL LAB
|
0 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
ASPARTATE AMINOTRANSFERASE, LOCAL LAB
|
3 Participants
|
4 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
ALANINE AMINOTRANSFERASE, LOCAL LAB
|
3 Participants
|
5 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
BILIRUBIN, TOTAL, LOCAL LAB
|
4 Participants
|
3 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HYPONATREMIA
|
5 Participants
|
4 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HYPERKALEMIA
|
1 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HYPOKALEMIA
|
1 Participants
|
4 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HYPERCALCEMIA
|
1 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Worst CTCAE Grade 3-4 Laboratory Parameters
HYPOGLYCEMIA
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 85Population: All Randomized Subjects \>= 18 years of age at baseline. Only participants with data at the timepoint were included in the analysis.
The FACT-M questionnaire was used to assess the effects of disease symptoms on functioning and well-being. As a generic cancer-related core, the FACT-M includes the 27-item FACT General (FACT-G) to assess physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). In addition, the FACT-M includes a 16-item disease-specific Melanoma Subscale (MS). Each FACT-M item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much). Scores for the PWB, FWB, SWB, and EWB subscales can be combined to produce a FACT-G total score, which provides an overall indicant of generic quality of life, while the FACT-G and MS scores can be combined to produce a total score for the FACT-M, which provides a composite measure of general and targeted quality of life. Overall scale ranges from 0 to 172, higher values indicate better functioning as well as lower symptom burden.
Outcome measures
| Measure |
Nivo + Rela FDC SC
n=7 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=8 Participants
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Change From Baseline Functional Assessment of Cancer Therapy -Melanoma (FACT-M) Total Score
|
9.76 Score on a scale
Standard Deviation 17.87
|
1.75 Score on a scale
Standard Deviation 15.33
|
Adverse Events
Nivo + Rela FDC SC
Serious events: 143 serious events
Other events: 242 other events
Deaths: 80 deaths
Nivo + Rela FDC IV
Serious events: 140 serious events
Other events: 261 other events
Deaths: 63 deaths
Serious adverse events
| Measure |
Nivo + Rela FDC SC
n=283 participants at risk
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 participants at risk
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.0%
3/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
5/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Atrial flutter
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Atrial thrombosis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Myocarditis
|
1.8%
5/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
2.1%
6/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.2%
9/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.7%
5/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Hyperadrenocorticism
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Hypophysitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.0%
3/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Hypopituitarism
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Immune-mediated adrenal insufficiency
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Thyroiditis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Eye disorders
Retinal detachment
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Eye disorders
Uveitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Colitis
|
3.5%
10/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
3/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Enteritis
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.0%
3/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Immune-mediated gastritis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.0%
3/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Asthenia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Death
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Disease progression
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
General physical health deterioration
|
1.1%
3/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
2.4%
7/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Mucosal inflammation
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Pain
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Polyserositis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Pyrexia
|
1.1%
3/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.4%
4/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Systemic inflammatory response syndrome
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Cholangitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.1%
3/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.0%
3/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Hepatobiliary disorders
Subcapsular hepatic haematoma
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Immune system disorders
Anaphylactic reaction
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Abdominal abscess
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Appendicitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Arthritis bacterial
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Clostridium difficile infection
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Cystitis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Diverticulitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Encephalitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Erysipelas
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Herpes zoster meningoencephalitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Infection
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Influenza
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Parotitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pneumonia
|
1.8%
5/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.4%
4/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pneumonia bacterial
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pneumonia fungal
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pneumonia influenzal
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pulmonary sepsis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Sepsis
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.4%
4/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Septic shock
|
1.4%
4/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Sinusitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Skin infection
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Soft tissue infection
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Wound infection
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Troponin I increased
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Blood bilirubin increased
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
General physical condition abnormal
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Troponin T increased
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Troponin increased
|
1.4%
4/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Weight decreased
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.4%
4/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.4%
4/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.5%
24/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
7.9%
23/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.1%
3/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.0%
3/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour hyperprogression
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
3/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Immune-mediated encephalopathy
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Ischaemic stroke
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Neurological symptom
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Presyncope
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Radicular pain
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Seizure
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Spinal cord compression
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Syncope
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Psychiatric disorders
Confusional state
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Psychiatric disorders
Delirium
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
1.7%
5/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Renal and urinary disorders
Nephritis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.69%
2/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Surgical and medical procedures
Anal sphincterotomy
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Embolism
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Hypotension
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Shock
|
0.00%
0/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.34%
1/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Vena cava thrombosis
|
0.35%
1/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
Other adverse events
| Measure |
Nivo + Rela FDC SC
n=283 participants at risk
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 960 mg + Relatlimab 320 mg FDC + 24,000 units rHuPH20 SC once in 4 weeks (Q4W).
|
Nivo + Rela FDC IV
n=291 participants at risk
Participants with Previously Untreated Metastatic or Unresectable Melanoma administered with fixed dose combination (FDC) Nivolumab 480 mg + Relatlimab 160 mg IV Q4W.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.2%
43/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
14.1%
41/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.7%
16/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
4.1%
12/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Hyperthyroidism
|
8.8%
25/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
10.0%
29/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Endocrine disorders
Hypothyroidism
|
20.8%
59/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
21.3%
62/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
22/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
5.8%
17/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Constipation
|
11.3%
32/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
11.3%
33/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.7%
53/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
16.2%
47/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
8/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
7.9%
23/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Nausea
|
16.3%
46/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
15.8%
46/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
20/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
7.6%
22/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Asthenia
|
15.9%
45/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
17.2%
50/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Fatigue
|
17.7%
50/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
26.1%
76/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Injection site reaction
|
11.0%
31/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
0.00%
0/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Oedema peripheral
|
7.4%
21/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
5.2%
15/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
General disorders and administration site conditions
Pyrexia
|
9.2%
26/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
6.9%
20/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
18/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
7.2%
21/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.71%
2/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
6.9%
20/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Alanine aminotransferase increased
|
9.9%
28/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
12.7%
37/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
27/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
8.2%
24/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
13.1%
37/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
10.7%
31/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Blood creatinine increased
|
3.5%
10/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
6.5%
19/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.0%
17/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
3.4%
10/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Troponin increased
|
5.3%
15/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
7.9%
23/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Investigations
Weight decreased
|
6.0%
17/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
6.9%
20/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.6%
30/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
11.3%
33/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.0%
17/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
4.8%
14/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.3%
49/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
18.9%
55/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
24/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
10.0%
29/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.9%
28/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
6.2%
18/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
16/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
5.2%
15/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Dizziness
|
5.7%
16/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
4.8%
14/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Nervous system disorders
Headache
|
8.8%
25/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
13.4%
39/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Psychiatric disorders
Insomnia
|
5.7%
16/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
4.5%
13/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
24/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
8.6%
25/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.6%
13/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
5.5%
16/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.8%
59/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
22.3%
65/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.7%
53/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
16.2%
47/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
12.4%
35/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
11.7%
34/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
|
Vascular disorders
Hypertension
|
6.0%
17/283 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
7.9%
23/291 • All cause mortality were collected from Day 1 and up to approximately 29 months. SAEs and Non SAEs were collected from first dose (Day 1) and 135 days after last dose of study therapy (up to approximately 29 months).
All-cause mortality was collected for all randomized participants and SAE and non-SAEs were collected for all treated participants.
|
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