Trial Outcomes & Findings for A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer (NCT NCT04702880)
NCT ID: NCT04702880
Last Updated: 2026-06-17
Results Overview
PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months)
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
Arm A
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm B
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Pre-treatment
STARTED
|
67
|
68
|
|
Pre-treatment
COMPLETED
|
66
|
65
|
|
Pre-treatment
NOT COMPLETED
|
1
|
3
|
|
Treatment - Induction Phase
STARTED
|
66
|
65
|
|
Treatment - Induction Phase
COMPLETED
|
56
|
53
|
|
Treatment - Induction Phase
NOT COMPLETED
|
10
|
12
|
|
Treatment - Maintenance Phase
STARTED
|
56
|
52
|
|
Treatment - Maintenance Phase
Did not enter Maintenance phase
|
0
|
1
|
|
Treatment - Maintenance Phase
COMPLETED
|
6
|
2
|
|
Treatment - Maintenance Phase
NOT COMPLETED
|
50
|
50
|
Reasons for withdrawal
| Measure |
Arm A
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm B
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Pre-treatment
Participant request to discontinue study treatment
|
0
|
1
|
|
Pre-treatment
Withdrawal by Subject
|
0
|
1
|
|
Pre-treatment
Participant no longer meets study criteria
|
1
|
0
|
|
Pre-treatment
Other reasons
|
0
|
1
|
|
Treatment - Induction Phase
Participant request to discontinue study
|
1
|
0
|
|
Treatment - Induction Phase
Withdrawal by Subject
|
0
|
1
|
|
Treatment - Induction Phase
Death
|
1
|
0
|
|
Treatment - Induction Phase
Disease progression
|
2
|
3
|
|
Treatment - Induction Phase
Study drug toxicity
|
3
|
6
|
|
Treatment - Induction Phase
Adverse Event unrelated to study drug
|
3
|
2
|
|
Treatment - Maintenance Phase
Withdrawal by Subject
|
0
|
1
|
|
Treatment - Maintenance Phase
Death
|
1
|
0
|
|
Treatment - Maintenance Phase
Disease progression
|
42
|
42
|
|
Treatment - Maintenance Phase
Study drug toxicity
|
1
|
4
|
|
Treatment - Maintenance Phase
Adverse event unrelated to study drug
|
2
|
0
|
|
Treatment - Maintenance Phase
other reasons
|
1
|
1
|
|
Treatment - Maintenance Phase
Participant request to discontinue study
|
2
|
1
|
|
Treatment - Maintenance Phase
transitioned to rollover study
|
1
|
1
|
Baseline Characteristics
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 7.29 • n=9 Participants
|
66.0 Years
STANDARD_DEVIATION 8.37 • n=27 Participants
|
66.0 Years
STANDARD_DEVIATION 7.82 • n=267 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=9 Participants
|
35 Participants
n=27 Participants
|
59 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=9 Participants
|
33 Participants
n=27 Participants
|
76 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=9 Participants
|
47 Participants
n=27 Participants
|
88 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
45 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=9 Participants
|
62 Participants
n=27 Participants
|
122 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants With Adverse Events
|
65 Participants
|
66 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)Population: All treated participants
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
34 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
|
16 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: From first dose to primary cutoff date (Up to approximately 43 months)Population: All treated participants
Number of participants who died due to any cause.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants Who Died
|
53 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: From randomization to the date of the first documented tumor progression, or death, or primary cutoff date, whichever occurs first (Up to approximately 50 months)Population: All randomized participants
PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
|
5.59 Months
Interval 4.86 to 6.57
|
5.78 Months
Interval 4.99 to 7.89
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: All randomized participants
PFSR is defined as the percentage of participants progression free at 6 and 12 months. PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Blinded Independent Central Review (BICR) and by investigator, or death from any cause. Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Progression Free Survival Rate (PFSR) at 6 and 12 Months
6 months - BICR
|
43.1 Percentage of participants
Interval 30.0 to 55.5
|
48.7 Percentage of participants
Interval 35.6 to 60.6
|
|
Progression Free Survival Rate (PFSR) at 6 and 12 Months
6 months - Investigator
|
42.8 Percentage of participants
Interval 30.1 to 55.0
|
56.4 Percentage of participants
Interval 43.1 to 67.7
|
|
Progression Free Survival Rate (PFSR) at 6 and 12 Months
12 months - BICR
|
22.2 Percentage of participants
Interval 12.2 to 34.0
|
21.0 Percentage of participants
Interval 11.4 to 32.5
|
|
Progression Free Survival Rate (PFSR) at 6 and 12 Months
12 months Investigator
|
19.6 Percentage of participants
Interval 10.6 to 30.8
|
18.1 Percentage of participants
Interval 9.6 to 28.7
|
SECONDARY outcome
Timeframe: From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months)Population: All randomized participants
PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by Investigator or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Progression Free Survival (PFS) Per Investigator
|
5.09 Months
Interval 4.76 to 6.67
|
6.47 Months
Interval 5.13 to 7.89
|
SECONDARY outcome
Timeframe: From randomization to the date of first documented response (Up to approximately 56 months)Population: All randomized participants
ORR per Blinded Independent Central Review (BICR) and per investigator is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Objective Response Rate (ORR)
Per BICR
|
66.2 Percentage of participants
Interval 53.7 to 77.2
|
73.1 Percentage of participants
Interval 60.9 to 83.2
|
|
Objective Response Rate (ORR)
Per Investigator
|
61.8 Percentage of participants
Interval 49.2 to 73.3
|
74.6 Percentage of participants
Interval 62.5 to 84.5
|
SECONDARY outcome
Timeframe: From randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier (Up to approximately 56 months)Population: All responders (CR+PR) per BICR and per Investigator
DoR per Blinded Independent Central Review and per investigator is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=45 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=50 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Duration of Response (DoR)
per BICR
|
4.50 Months
Interval 3.48 to 5.49
|
6.41 Months
Interval 4.3 to 7.39
|
|
Duration of Response (DoR)
per Investigator
|
4.96 Months
Interval 3.48 to 6.7
|
5.29 Months
Interval 4.73 to 6.87
|
SECONDARY outcome
Timeframe: From randomization to the date of first documented CR or PR (Up to approximately 56 months)Population: All responders (CR+PR) per BICR and per Investigator
TTR per Blinded Independent Central Review (BICR) and per investigator is defined for participants who had a confirmed CR or PR as the time from the date of randomization to date of first documented CR or PR per RECIST v1.1. CR=Disappearance of all target lesions. PR=At least 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=45 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=50 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Time to Response (TTR)
per BICR
|
1.58 Months
Interval 1.2 to 5.2
|
1.51 Months
Interval 1.3 to 3.0
|
|
Time to Response (TTR)
per Investigator
|
1.63 Months
Interval 1.2 to 18.1
|
1.51 Months
Interval 1.2 to 5.0
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause (Up to approximately 56 months)Population: All randomized participants
OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Overall Survival (OS)
|
13.08 Months
Interval 9.72 to 16.62
|
16.26 Months
Interval 12.22 to 23.66
|
SECONDARY outcome
Timeframe: 12 and 24 monthsPopulation: All randomized participants
OSR is defined as the percentage of participants surviving at 12 and 24 months. OS is defined as the time from randomization to the time of death due to any cause. OS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Overall Survival Rate (OSR) at 12 and 24 Months
12 months
|
51.7 Percentage of participants
Interval 38.8 to 63.0
|
64.7 Percentage of participants
Interval 51.9 to 75.0
|
|
Overall Survival Rate (OSR) at 12 and 24 Months
24 months
|
25.0 Percentage of participants
Interval 15.2 to 36.1
|
37.8 Percentage of participants
Interval 26.1 to 49.5
|
SECONDARY outcome
Timeframe: From baseline up to approximately 56 monthsPopulation: All treated participants with baseline immunogenicity assessments in arm A only as pre-specified
ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment. Baseline ADA Positive: A participant with baseline ADA-positive sample.
Outcome measures
| Measure |
Arm B
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=57 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants With Anti-Nivolumab Antibody (ADA)
BMS-986012 ADA Positive
|
—
|
2 Participants
|
|
Number of Participants With Anti-Nivolumab Antibody (ADA)
Nivolumab ADA Positive
|
—
|
4 Participants
|
POST_HOC outcome
Timeframe: From first dose to 100 days post last dose (Up to approximately 47 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants With Adverse Events - Extended Collection
|
65 Participants
|
66 Participants
|
POST_HOC outcome
Timeframe: From first dose to 100 days post last dose (Up to approximately 47 months)Population: All treated participants
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants With Serious Adverse Events - Extended Collection
|
34 Participants
|
38 Participants
|
POST_HOC outcome
Timeframe: From first dose to 100 days post last dose (Up to approximately 47 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation - Extended Collection
|
15 Participants
|
13 Participants
|
POST_HOC outcome
Timeframe: From first dose to 100 days post last dose (Up to approximately 47 months)Population: All treated participants
Number of participants who died due to any cause.
Outcome measures
| Measure |
Arm B
n=65 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=66 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Number of Participants Who Died - Extended Collection
|
56 Participants
|
50 Participants
|
POST_HOC outcome
Timeframe: From randomization to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 56 months)Population: All randomized participants
PFS based on RECIST v1.1 is defined as the time from randomization to the date of the first documented tumor progression by BICR or death from any cause. Estimates are based on Kaplan-Meier product-limit method. Progressive disease=At least a 20% increase in the sum of diameters of target lesions.
Outcome measures
| Measure |
Arm B
n=68 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm A
n=67 Participants
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) - Extended Collection
|
5.59 Months
Interval 4.86 to 6.57
|
5.78 Months
Interval 4.99 to 7.89
|
Adverse Events
Arm A
Serious events: 38 serious events
Other events: 62 other events
Deaths: 50 deaths
Arm B
Serious events: 34 serious events
Other events: 62 other events
Deaths: 56 deaths
Serious adverse events
| Measure |
Arm A
n=66 participants at risk
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm B
n=65 participants at risk
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
3/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
5/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
2/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiogenic shock
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericarditis
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Asthenia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Death
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Pain
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Pyrexia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Sudden death
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatitis
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Appendicitis
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Campylobacter gastroenteritis
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile colitis
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Coronavirus pneumonia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Encephalitis
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
2/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.6%
3/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Amylase increased
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
General physical condition abnormal
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Dermatomyositis
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenomyoepithelioma of breast
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
9.1%
6/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.6%
3/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Aphasia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Balance disorder
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Loss of consciousness
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Migraine
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neurological decompensation
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Presyncope
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Seizure
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
2/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Arm A
n=66 participants at risk
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with BMS-986012 420 mg IV and Nivolumab 360 mg IV followed by BMS-986012 560 mg IV and Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
Arm B
n=65 participants at risk
Participants received 4 cycles of induction therapy (21 days per cycle) of Carboplatin 5 mg/mL/min IV + Etoposide 100 mg/m\^2 IV in combination with Nivolumab 360 mg IV followed by Nivolumab 480 mg IV as maintenance (28 days per cycle)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
39.4%
26/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
60.0%
39/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
6/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
22/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.3%
21/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
22/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.3%
21/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
3/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
10/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Eye pruritus
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
3/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
22.7%
15/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.1%
15/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
18/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.5%
12/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
28.8%
19/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
35.4%
23/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
7.6%
5/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
5/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.5%
14/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Amylase increased
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Asthenia
|
13.6%
9/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.5%
14/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Chest pain
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
5/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Fatigue
|
25.8%
17/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
10/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Malaise
|
9.1%
6/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.6%
3/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Mucosal inflammation
|
0.00%
0/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Oedema peripheral
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.2%
6/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders and administration site conditions
Pyrexia
|
7.6%
5/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.6%
3/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
10.6%
7/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
10.6%
7/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
2/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
10.6%
7/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
8/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
11/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.6%
3/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
9/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
7.6%
5/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.6%
3/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lipase increased
|
10.6%
7/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
5/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.7%
13/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
24.6%
16/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.0%
2/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
6/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
8/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.8%
7/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.2%
12/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.8%
9/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
7/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
8/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
12/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
8/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
7.6%
5/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
5/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysgeusia
|
15.2%
10/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
12.1%
8/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.8%
9/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
7.6%
5/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
2/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraesthesia
|
9.1%
6/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
4/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
10.6%
7/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
5/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
8/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
8/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.7%
13/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.8%
7/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.1%
4/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.5%
1/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.3%
20/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
27.7%
18/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.6%
5/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
62.1%
41/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.5%
12/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.7%
13/66 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.8%
7/65 • All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 56 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 100 days post last dose (Up to approximately 47 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
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