Trial Outcomes & Findings for Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (NCT NCT02388906)
NCT ID: NCT02388906
Last Updated: 2025-04-24
Results Overview
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
906 participants
Primary outcome timeframe
up to 36 months
Results posted on
2025-04-24
Participant Flow
906 participants randomized and 905 treated. Reason for not treated: 1 participant withdrew consent.
Participant milestones
| Measure |
Nivolumab 3 mg/kg
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Pre-Treatment Period
STARTED
|
453
|
453
|
|
Pre-Treatment Period
COMPLETED
|
452
|
453
|
|
Pre-Treatment Period
NOT COMPLETED
|
1
|
0
|
|
Treatment Period
STARTED
|
452
|
453
|
|
Treatment Period
COMPLETED
|
275
|
123
|
|
Treatment Period
NOT COMPLETED
|
177
|
330
|
Reasons for withdrawal
| Measure |
Nivolumab 3 mg/kg
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Pre-Treatment Period
Participant withdrew consent
|
1
|
0
|
|
Treatment Period
Disease progression
|
121
|
100
|
|
Treatment Period
Study drug toxicity
|
41
|
208
|
|
Treatment Period
Adverse Event (AE) unrelated to study drug
|
5
|
5
|
|
Treatment Period
Participant request to stop treatment
|
5
|
9
|
|
Treatment Period
Participant withdrew consent
|
2
|
3
|
|
Treatment Period
Poor/non-compliance
|
0
|
1
|
|
Treatment Period
Participant no longer meets study criteria
|
0
|
1
|
|
Treatment Period
Other reasons
|
3
|
3
|
Baseline Characteristics
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Nivolumab 3 mg/kg
n=453 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
Total
n=906 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 13.34 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 13.50 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 13.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
527 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
215 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
232 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
469 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
425 Participants
n=5 Participants
|
434 Participants
n=7 Participants
|
859 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 36 monthsPopulation: All randomized participants
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=453 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Recurrence-free Survival (RFS)
|
52.37 Months
Interval 42.51 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
24.08 Months
Interval 16.56 to 35.09
|
SECONDARY outcome
Timeframe: up to 106.6 monthsPopulation: All randomized Participants
OS is defined as as the time between the date of randomization and the date of death.
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=453 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Median not reached due to insufficient death events
|
NA Months
Median not reached due to insufficient death events
|
SECONDARY outcome
Timeframe: reported between first dose and 30 days after last dose of study therapyPopulation: All treated participants
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=452 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
Grade 3-4
|
116 Participants
|
251 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
Any grade
|
440 Participants
|
446 Participants
|
SECONDARY outcome
Timeframe: reported between the first dose and 30 days after last dose of study therapyPopulation: all treated participants
The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=452 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
Grade 3-4
|
48 Participants
|
145 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
Any grade
|
80 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: reported between first dose and 30 to 100 days after last dose of study therapyPopulation: All treated participants
the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=452 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths
|
128 Participants
|
142 Participants
|
SECONDARY outcome
Timeframe: reported after first dose and within 30 days of last dose of the study therapyPopulation: Participants with a CTC graded Laboratory Result for the given parameter from both Baseline and On-treatment
The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=452 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Heamoglobin (grade1-4)
|
114 Participants
|
148 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Heamoglobin (Grade 3-4)
|
0 Participants
|
2 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Platelet count (grade1-4)
|
27 Participants
|
25 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Platelet count ( grade 3-4)
|
0 Participants
|
1 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Leukocytes (grade1-4)
|
62 Participants
|
12 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Leukocytes (grade 3-4)
|
0 Participants
|
1 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Lymphocytes (grade1-4)
|
118 Participants
|
54 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Lymphocytes (grade 3-4)
|
2 Participants
|
4 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Absolute Neutrophil count (Grade1-4)
|
56 Participants
|
26 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Absolute Neutrophil count (Grade3-4)
|
0 Participants
|
2 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Alkaline Phosphatase (grade1-4)
|
35 Participants
|
69 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Alkaline Phosphatase (Grade3-4)
|
1 Participants
|
3 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Aspartate Aminotransferase (grade 1-4)
|
105 Participants
|
144 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Aspartate Aminotransferase(grade 3-4)
|
6 Participants
|
39 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Alkaline Aminotransferase (grade 1-4)
|
113 Participants
|
176 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Alkaline Aminotransferase(grade 3-4)
|
8 Participants
|
52 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Total Bilirubin (grade 1-4)
|
33 Participants
|
43 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Total Bilirubin (grade 3-4)
|
0 Participants
|
5 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Creatinine ( grade1-4)
|
55 Participants
|
56 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Creatinine (grade 3-4)
|
0 Participants
|
0 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Total Amylase ( grade1-4)
|
68 Participants
|
52 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Total Amylase (grade 3-4)
|
13 Participants
|
12 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Total Lipase ( grade1-4)
|
109 Participants
|
100 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Total Lipase (grade 3-4)
|
31 Participants
|
38 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypernatremia ( grade1-4)
|
35 Participants
|
20 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypernatremia (grade 3-4)
|
0 Participants
|
0 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hyponatremia ( grade1-4)
|
72 Participants
|
96 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hyponatremia (grade 3-4)
|
5 Participants
|
14 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hyperkalemia ( grade1-4)
|
55 Participants
|
39 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hyperkalemia (grade 3-4)
|
1 Participants
|
2 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypokalemia ( grade1-4)
|
37 Participants
|
45 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypokalemia(grade 3-4)
|
5 Participants
|
9 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypercalcemia ( grade1-4)
|
14 Participants
|
18 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypercalcemia(grade 3-4)
|
0 Participants
|
0 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypocalcemia ( grade1-4)
|
46 Participants
|
73 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypocalcemia(grade 3-4)
|
3 Participants
|
2 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypermagnesemia ( grade1-4)
|
20 Participants
|
7 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypermagnesemia(grade 3-4)
|
2 Participants
|
1 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypomagnesemia ( grade1-4)
|
39 Participants
|
32 Participants
|
|
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Hypomagnesemia(grade 3-4)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 106.6 monthsPopulation: All randomized Participants
Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=453 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Recurrence-free Survival by PD-L1 Expression
Participants with >= 5% PD-L1 Expression,
|
70.41 Months
Interval 67.65 to 84.8
|
54.67 Months
Interval 24.15 to 84.4
|
|
Recurrence-free Survival by PD-L1 Expression
Participants with < 5% PD-L1 Expression,
|
38.677 Months
Interval 22.05 to 61.04
|
16.56 Months
Interval 11.14 to 26.51
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: All randomized Participants with values from the second follow-up visit
HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants. EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=334 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=308 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Health Related Quality of Life (HRQoL) Evaluation
Physical functioning
|
-2.04 Scores on a scale
Standard Deviation 15.134
|
-4.88 Scores on a scale
Standard Deviation 15.713
|
|
Health Related Quality of Life (HRQoL) Evaluation
Role functioning
|
-2.43 Scores on a scale
Standard Deviation 25.219
|
-3.85 Scores on a scale
Standard Deviation 29.951
|
|
Health Related Quality of Life (HRQoL) Evaluation
Emotional functioning
|
0.18 Scores on a scale
Standard Deviation 20.282
|
1.43 Scores on a scale
Standard Deviation 17.911
|
|
Health Related Quality of Life (HRQoL) Evaluation
Cognitive functioning
|
-3.74 Scores on a scale
Standard Deviation 18.364
|
-4.67 Scores on a scale
Standard Deviation 16.664
|
|
Health Related Quality of Life (HRQoL) Evaluation
Social functioning
|
-0.51 Scores on a scale
Standard Deviation 22.085
|
-3.53 Scores on a scale
Standard Deviation 26.391
|
|
Health Related Quality of Life (HRQoL) Evaluation
Global health status
|
-5.81 Scores on a scale
Standard Deviation 20.046
|
-7.00 Scores on a scale
Standard Deviation 23.109
|
|
Health Related Quality of Life (HRQoL) Evaluation
Fatigue
|
6.45 Scores on a scale
Standard Deviation 21.605
|
9.05 Scores on a scale
Standard Deviation 23.475
|
|
Health Related Quality of Life (HRQoL) Evaluation
Nausea and vomiting
|
2.23 Scores on a scale
Standard Deviation 12.622
|
1.90 Scores on a scale
Standard Deviation 11.473
|
|
Health Related Quality of Life (HRQoL) Evaluation
Pain
|
1.66 Scores on a scale
Standard Deviation 23.314
|
4.38 Scores on a scale
Standard Deviation 23.641
|
|
Health Related Quality of Life (HRQoL) Evaluation
Dyspnea
|
7.32 Scores on a scale
Standard Deviation 22.741
|
5.45 Scores on a scale
Standard Deviation 20.364
|
|
Health Related Quality of Life (HRQoL) Evaluation
Insomnia
|
1.82 Scores on a scale
Standard Deviation 28.692
|
3.05 Scores on a scale
Standard Deviation 28.785
|
|
Health Related Quality of Life (HRQoL) Evaluation
Appetite loss
|
4.07 Scores on a scale
Standard Deviation 22.660
|
2.61 Scores on a scale
Standard Deviation 19.257
|
|
Health Related Quality of Life (HRQoL) Evaluation
Constipation
|
1.11 Scores on a scale
Standard Deviation 17.904
|
0.33 Scores on a scale
Standard Deviation 18.373
|
|
Health Related Quality of Life (HRQoL) Evaluation
Diarrhea
|
1.31 Scores on a scale
Standard Deviation 20.831
|
3.38 Scores on a scale
Standard Deviation 21.242
|
|
Health Related Quality of Life (HRQoL) Evaluation
Financial difficulties
|
-1.41 Scores on a scale
Standard Deviation 23.348
|
0.54 Scores on a scale
Standard Deviation 20.282
|
POST_HOC outcome
Timeframe: up to 114 monthsPopulation: All randomized participants
RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
Outcome measures
| Measure |
Nivolumab 3 mg/kg
n=453 Participants
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 Participants
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Recurrence-free Survival (RFS)
|
61.14 Months
Interval 42.87 to 89.23
|
24.15 Months
Interval 16.56 to 35.12
|
Adverse Events
Nivolumab 3 mg/kg
Serious events: 106 serious events
Other events: 421 other events
Deaths: 128 deaths
Ipilimumab 10 mg/kg
Serious events: 215 serious events
Other events: 438 other events
Deaths: 142 deaths
Serious adverse events
| Measure |
Nivolumab 3 mg/kg
n=452 participants at risk
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 participants at risk
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infected seroma
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infection
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infectious mononucleosis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lower respiratory tract infection
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningitis aseptic
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma
|
1.1%
5/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma of the tongue
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anaemia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymph node pain
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphadenopathy
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphadenopathy mediastinal
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Thrombotic thrombocytopenic purpura
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Angina pectoris
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bradycardia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Left ventricular dysfunction
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myocardial ischaemia
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
5/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 suppression
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Adrenocortical insufficiency acute
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Glucocorticoid deficiency
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperthyroidism
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.66%
3/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.0%
18/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypopituitarism
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypothalamo-pituitary disorder
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphocytic hypophysitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
5/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Uveitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vision blurred
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 upper
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune colitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
5/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Colitis
|
1.1%
5/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.1%
41/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
5/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.2%
37/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Duodenitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Enteritis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Enterocolitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastric ulcer
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastritis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastrointestinal perforation
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Glossitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ileus
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated enterocolitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intestinal perforation
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intussusception
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 intestinal haemorrhage
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Proctitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Small intestinal obstruction
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Asthenia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Facial pain
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperthermia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza like illness
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Malaise
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mucosal inflammation
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Non-cardiac chest pain
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pyrexia
|
1.8%
8/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
11/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune hepatitis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cholecystitis acute
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cholestasis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Drug-induced liver injury
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatic cytolysis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatic function abnormal
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatic haemorrhage
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
7/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 acute
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatobiliary disease
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypertransaminasaemia
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated hepatitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Sarcoidosis
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anorectal infection
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacteraemia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacterial infection
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Brain abscess
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchitis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
7/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Device related infection
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Erysipelas
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fungal sepsis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mucormycosis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myelitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pharyngitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pharyngotonsillitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.88%
4/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
6/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 fungal
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pulmonary sepsis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rash pustular
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sinobronchitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sinusitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Skin infection
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Soft tissue infection
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Staphylococcal bacteraemia
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Staphylococcal infection
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tonsillitis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urosepsis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Viral infection
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wound infection
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Craniocerebral injury
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hand fracture
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Incisional hernia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Post procedural haematoma
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vascular pseudoaneurysm
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
5/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bilirubin increased
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 creatine phosphokinase increased
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Body temperature increased
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Electrocardiogram abnormal
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Faecal volume increased
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatic enzyme increased
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Liver function test increased
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutrophil count decreased
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Transaminases increased
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
5/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dehydration
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
4/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diabetes mellitus inadequate control
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fulminant type 1 diabetes mellitus
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperglycaemia
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperkalaemia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Type 1 diabetes mellitus
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arthritis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Musculoskeletal chest pain
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myalgia
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neck pain
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rheumatoid arthritis
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Temporomandibular pain and dysfunction syndrome
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Adenocarcinoma of colon
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Basal cell carcinoma
|
0.66%
3/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Bowen's disease
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Breast cancer
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Cancer pain
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Chronic lymphocytic leukaemia
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 melanoma
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.88%
4/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Melanoma recurrent
|
2.2%
10/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Metastatic malignant melanoma
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 malignant
|
0.66%
3/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 recurrence
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Papillary thyroid cancer
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Renal cell carcinoma
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bell's palsy
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cerebrovascular accident
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysarthria
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Encephalopathy
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Facial nerve disorder
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhage intracranial
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
4/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypotonia
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
IVth nerve disorder
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Miller Fisher syndrome
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neurosarcoidosis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Polyneuropathy
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Syncope
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.66%
3/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Transient ischaemic attack
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dependence
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.66%
3/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cystitis haemorrhagic
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nephrolithiasis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 colic
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tubulointerstitial nephritis
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Asthma
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune lung disease
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Capillary leak syndrome
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated lung disease
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Interstitial lung disease
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lung disorder
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lung infiltration
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Obstructive airways disorder
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
5/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumothorax
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
4/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Acne
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dermatitis exfoliative generalised
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Drug reaction with eosinophilia and systemic symptoms
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Eczema
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
4/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 maculo-papular
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Skin toxicity
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Toxic skin eruption
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urticaria
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Giant cell arteritis
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypertension
|
0.22%
1/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.44%
2/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.44%
2/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Orthostatic hypotension
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Venous thrombosis limb
|
0.00%
0/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.22%
1/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 |
Nivolumab 3 mg/kg
n=452 participants at risk
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
|
Ipilimumab 10 mg/kg
n=453 participants at risk
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
13/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
26/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperthyroidism
|
8.2%
37/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.9%
22/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.3%
6/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.3%
42/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.7%
53/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
35/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.7%
53/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.2%
78/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 upper
|
7.3%
33/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
21/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Colitis
|
2.2%
10/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.6%
30/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.4%
47/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.2%
46/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
37.8%
171/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
55.2%
250/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dry mouth
|
7.3%
33/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
23/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dyspepsia
|
4.6%
21/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.0%
27/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
24.3%
110/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.8%
135/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.6%
39/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.0%
68/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Asthenia
|
16.4%
74/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.9%
72/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chills
|
2.4%
11/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.8%
31/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fatigue
|
42.7%
193/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
43.5%
197/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza like illness
|
7.1%
32/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.6%
39/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oedema peripheral
|
5.3%
24/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
29/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pyrexia
|
8.6%
39/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.2%
105/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nasopharyngitis
|
11.7%
53/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
24/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.5%
43/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
32/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.4%
38/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.4%
88/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.4%
29/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
26/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.9%
31/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.6%
75/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.88%
4/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
26/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.0%
36/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.1%
41/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Weight decreased
|
2.4%
11/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
35/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.5%
43/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.2%
69/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.8%
103/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.7%
80/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.8%
49/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.2%
46/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myalgia
|
13.3%
60/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
35/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pain in extremity
|
9.3%
42/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.9%
36/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.4%
47/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.6%
39/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
24.1%
109/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.7%
148/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.5%
25/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
21/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.7%
35/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
43/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.6%
84/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.3%
83/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.5%
34/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.9%
45/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nasal congestion
|
5.3%
24/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
17/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oropharyngeal pain
|
6.6%
30/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.2%
37/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Erythema
|
6.9%
31/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
23/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
30.1%
136/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
39.5%
179/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
27.0%
122/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
36.6%
166/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 maculo-papular
|
6.0%
27/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.5%
52/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypertension
|
7.3%
33/452 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
24/453 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
- Publication restrictions are in place
Restriction type: LTE60