Trial Outcomes & Findings for A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma (NCT NCT05002569)
NCT ID: NCT05002569
Last Updated: 2026-01-08
Results Overview
RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1093 participants
Primary outcome timeframe
Approximately 27.5 Months
Results posted on
2026-01-08
Participant Flow
1093 participants randomized and 1088 treated.
Participant milestones
| Measure |
Treatment 1
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Randomized
STARTED
|
547
|
546
|
|
Randomized
COMPLETED
|
543
|
545
|
|
Randomized
NOT COMPLETED
|
4
|
1
|
|
Treatment Period
STARTED
|
543
|
545
|
|
Treatment Period
COMPLETED
|
283
|
327
|
|
Treatment Period
NOT COMPLETED
|
260
|
218
|
|
Follow Up
STARTED
|
543
|
545
|
|
Follow Up
COMPLETED
|
1
|
5
|
|
Follow Up
NOT COMPLETED
|
542
|
540
|
Reasons for withdrawal
| Measure |
Treatment 1
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Randomized
Withdrew Consent
|
3
|
0
|
|
Randomized
No longer meets study criteria
|
0
|
1
|
|
Randomized
AE unrelated to study drug
|
1
|
0
|
|
Treatment Period
Requested to Discontinue
|
26
|
5
|
|
Treatment Period
Withdrew Consent
|
7
|
1
|
|
Treatment Period
Study Drug Toxicity
|
114
|
64
|
|
Treatment Period
AE unrelated to study drug
|
6
|
12
|
|
Treatment Period
Disease Recurrence
|
102
|
128
|
|
Treatment Period
Other Reasons
|
4
|
7
|
|
Treatment Period
Death
|
1
|
1
|
|
Follow Up
Death
|
78
|
69
|
|
Follow Up
Lost to Follow-up
|
3
|
3
|
|
Follow Up
Withdrew consent
|
17
|
16
|
|
Follow Up
Other Reasons
|
444
|
452
|
Baseline Characteristics
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Baseline characteristics by cohort
| Measure |
Treatment 1
n=547 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=546 Participants
nivolumab 480 mg IV Q4W
|
Total
n=1093 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 14.16 • n=18 Participants
|
57.6 Years
STANDARD_DEVIATION 13.34 • n=17 Participants
|
57.4 Years
STANDARD_DEVIATION 13.75 • n=35 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=18 Participants
|
231 Participants
n=17 Participants
|
451 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
327 Participants
n=18 Participants
|
315 Participants
n=17 Participants
|
642 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=18 Participants
|
39 Participants
n=17 Participants
|
85 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
280 Participants
n=18 Participants
|
269 Participants
n=17 Participants
|
549 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
221 Participants
n=18 Participants
|
238 Participants
n=17 Participants
|
459 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=18 Participants
|
37 Participants
n=17 Participants
|
76 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
491 Participants
n=18 Participants
|
497 Participants
n=17 Participants
|
988 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=18 Participants
|
10 Participants
n=17 Participants
|
24 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Randomized Participants
RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma) or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Treatment 1
n=547 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=546 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Recurrence Free Survival (RFS)
|
NA Months
Interval 0.0 to 37.7
Insufficient number of participants with events to calculate via KM Methodology
|
33.84 Months
Interval 0.0 to 37.7
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Randomized Participants
OS is defined as the time between the date of randomization and the date of death due to any cause.
Outcome measures
| Measure |
Treatment 1
n=547 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=546 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Insufficient number of participants with events to calculate via KM Methodology
|
NA Months
Insufficient number of participants with events to calculate via KM Methodology
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Randomized Participants with Resected Stage 3/4a/4b Melanoma at study entry
DMFS is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Treatment 1
n=499 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=494 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Distant Metastasis Free Survival (DMFS)
|
NA Months
Insufficient number of participants with events to calculate via KM Methodology
|
NA Months
Interval 33.84 to
Insufficient number of participants with events to calculate via KM Methodology
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Randomized Participants
PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Treatment 1
n=547 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=546 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Progression Free Survival on Next-Line Systemic Therapy (PFS2)
|
NA Months
Insufficient number of participants with events to calculate via KM Methodology
|
NA Months
Insufficient number of participants with events to calculate via KM Methodology
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Treated Population
Safety related events encompass the following measures: Adverse events (AEs), Serious AEs, AEs leading to discontinuation, Drug-Related AEs and Deaths. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An SAE is an AE which: * Results in death * Is life threatening * Requires hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event
Outcome measures
| Measure |
Treatment 1
n=543 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=545 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Number of Participants With Safety Related Events
AEs
|
522 Participants
|
520 Participants
|
|
Number of Participants With Safety Related Events
Drug-Related AEs
|
483 Participants
|
438 Participants
|
|
Number of Participants With Safety Related Events
Serious AEs
|
132 Participants
|
78 Participants
|
|
Number of Participants With Safety Related Events
AEs leading to discontinuation
|
102 Participants
|
65 Participants
|
|
Number of Participants With Safety Related Events
Deaths
|
83 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Treated Population
Select AEs will be reported as AEs per organ class. Organ classes which will be reported: * Gastrointestinal * Hepatic * Pulmonary * Renal * Skin * Hypersensitivity/Infusion reaction
Outcome measures
| Measure |
Treatment 1
n=543 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=545 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Number of Participants With Select AEs
Gastrointestinal
|
115 Participants
|
120 Participants
|
|
Number of Participants With Select AEs
Hepatic
|
108 Participants
|
86 Participants
|
|
Number of Participants With Select AEs
Pulmonary
|
11 Participants
|
13 Participants
|
|
Number of Participants With Select AEs
Renal
|
33 Participants
|
21 Participants
|
|
Number of Participants With Select AEs
Skin
|
244 Participants
|
240 Participants
|
|
Number of Participants With Select AEs
Hypersensitivity/Infusion Reaction
|
37 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Treated Population
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Outcome measures
| Measure |
Treatment 1
n=543 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=545 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Number of Participants With Endocrine Related Immune Mediated AEs
Adrenal Insufficiency
|
33 Participants
|
9 Participants
|
|
Number of Participants With Endocrine Related Immune Mediated AEs
Hypothyroidism/Thyroiditis
|
158 Participants
|
93 Participants
|
|
Number of Participants With Endocrine Related Immune Mediated AEs
Hypothyroidism
|
152 Participants
|
82 Participants
|
|
Number of Participants With Endocrine Related Immune Mediated AEs
Thyroiditis
|
18 Participants
|
14 Participants
|
|
Number of Participants With Endocrine Related Immune Mediated AEs
Diabetes Melitus
|
11 Participants
|
8 Participants
|
|
Number of Participants With Endocrine Related Immune Mediated AEs
Hyperthyroidism
|
96 Participants
|
56 Participants
|
|
Number of Participants With Endocrine Related Immune Mediated AEs
Hypophysitis
|
51 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Treated Population
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Outcome measures
| Measure |
Treatment 1
n=543 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=545 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Number of Participants With Non-endocrine Related Immune Mediated AEs
Pneumonitis
|
8 Participants
|
10 Participants
|
|
Number of Participants With Non-endocrine Related Immune Mediated AEs
Diarrhea/colitis
|
28 Participants
|
21 Participants
|
|
Number of Participants With Non-endocrine Related Immune Mediated AEs
Hepatitis
|
26 Participants
|
17 Participants
|
|
Number of Participants With Non-endocrine Related Immune Mediated AEs
Nephritis and Renal Dysfunction
|
3 Participants
|
3 Participants
|
|
Number of Participants With Non-endocrine Related Immune Mediated AEs
Rash
|
49 Participants
|
40 Participants
|
|
Number of Participants With Non-endocrine Related Immune Mediated AEs
Hypersensitivity
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Approximately 27.5 MonthsPopulation: All Treated Participants with at least one on treatment TSH measurement
Number of participants with laboratory abnormalities in specific thyroid tests.
Outcome measures
| Measure |
Treatment 1
n=524 Participants
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=534 Participants
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES ≤ ULN
|
117 Participants
|
85 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
119 Participants
|
72 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH < LLN
|
198 Participants
|
131 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH <LLN WITH TSH ≥ LLN AT BASELINE
|
180 Participants
|
123 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH < LLN WITH FT3/FT4 TEST MISSING
|
27 Participants
|
19 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH > ULN
|
229 Participants
|
159 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH > ULN WITH TSH ≤ ULN AT BASELINE
|
193 Participants
|
124 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
148 Participants
|
74 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES ≥ LLN
|
168 Participants
|
124 Participants
|
|
Laboratory Abnormalities for Specific Thyroid Tests
TSH > ULN WITH FT3/FT4 TEST MISSING
|
52 Participants
|
28 Participants
|
Adverse Events
Treatment 1
Serious events: 174 serious events
Other events: 489 other events
Deaths: 86 deaths
Treatment 2
Serious events: 121 serious events
Other events: 473 other events
Deaths: 76 deaths
Serious adverse events
| Measure |
Treatment 1
n=543 participants at risk
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=545 participants at risk
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Eye disorders
Amaurosis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Death
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune haemolytic anaemia
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemolysis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemolytic anaemia
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.55%
3/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sarcoidosis of lymph node
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Acute myocardial infarction
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Aortic valve stenosis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune myocarditis
|
0.55%
3/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.55%
3/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Coronary artery disease
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 infarction
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myocarditis
|
1.5%
8/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Prinzmetal angina
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ventricular fibrillation
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vertigo
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.4%
13/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.55%
3/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated adrenal insufficiency
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated hypophysitis
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Retinal detachment
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vitreous haemorrhage
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anal fistula
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ascites
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.92%
5/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.92%
5/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.55%
3/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Duodenal ulcer
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysphagia
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Eosinophilic gastritis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Food poisoning
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 polyps
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhoids
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.55%
3/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 gastritis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lower gastrointestinal haemorrhage
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chest pain
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
General physical health deterioration
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Generalised oedema
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated polyserositis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Serositis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sudden death
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Biliary tract disorder
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cholelithiasis
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Venoocclusive liver disease
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemophagocytic lymphohistiocytosis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Campylobacter colitis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Complicated appendicitis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cystitis escherichia
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Endocarditis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gastroenteritis viral
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Herpes zoster
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Kidney infection
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Large intestine infection
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Peritonitis
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 parainfluenzae viral
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Postoperative wound infection
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pyelonephritis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.55%
3/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 sepsis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Clavicle fracture
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fall
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Femur fracture
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 complication circulatory
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rib fracture
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Seroma
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Stoma site haemorrhage
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wound
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Wrist fracture
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.55%
3/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Norovirus test positive
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Troponin I increased
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Troponin T increased
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Troponin increased
|
0.55%
3/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Diabetic ketoacidosis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.73%
4/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.55%
3/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.55%
3/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
6/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 2 diabetes mellitus
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune myositis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bursitis
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Crystal arthropathy
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated myositis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intervertebral disc protrusion
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Muscle spasms
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Muscular weakness
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myositis
|
1.7%
9/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Osteoarthritis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rhabdomyolysis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.73%
4/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Basosquamous carcinoma of skin
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Bladder transitional cell carcinoma
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Follicular lymphoma
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Gastrointestinal tract adenoma
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Intraductal proliferative breast lesion
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Lung adenocarcinoma
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
12/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.55%
3/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.55%
3/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Pancreatic neuroendocrine tumour
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Recurrent cancer
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.92%
5/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 skin
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Altered state of consciousness
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cerebellar stroke
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cerebral haematoma
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cerebral ischaemia
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cognitive disorder
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Demyelinating polyneuropathy
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Guillain-Barre syndrome
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hydrocephalus
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated myasthenia gravis
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated myelitis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intracranial pressure increased
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myasthenia gravis
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myelitis transverse
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neuralgia
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Optic neuritis
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 motor neuropathy
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Presyncope
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Seizure
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Completed suicide
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mania
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mental disorder
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haematuria
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Immune-mediated nephritis
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Nephritis
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urinary bladder polyp
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Genital pain
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
4/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.73%
4/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.37%
2/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 allergic
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 eruption
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Erythrodermic psoriasis
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pemphigoid
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sarcoid-like reaction
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 mass
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Surgical and medical procedures
Skin cosmetic procedure
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Aortic aneurysm
|
0.18%
1/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.37%
2/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Peripheral arterial occlusive disease
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Poor venous access
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Shock haemorrhagic
|
0.00%
0/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.18%
1/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 |
Treatment 1
n=543 participants at risk
nivolumab 480 mg and relatlimab 160 mg IV every 4 weeks (Q4W)
|
Treatment 2
n=545 participants at risk
nivolumab 480 mg IV Q4W
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
31/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
24/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.1%
44/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
32/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.0%
114/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.5%
117/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.6%
36/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
25/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.7%
96/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.0%
60/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.8%
37/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
10/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
27.6%
150/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.6%
85/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.9%
59/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
36/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.8%
86/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
54/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
29/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
31/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.5%
68/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.7%
69/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
29.7%
161/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.5%
161/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.5%
30/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
23/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.2%
39/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
32/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
14.4%
78/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.2%
110/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
31/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
32/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.3%
29/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.5%
19/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.7%
69/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
57/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.9%
59/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.0%
49/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.0%
27/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
35/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.5%
46/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.1%
17/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
29/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
29/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.4%
100/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.2%
110/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.2%
39/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.5%
30/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.7%
47/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
47/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.7%
20/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.5%
30/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
29/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
29/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.6%
74/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
94/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.0%
60/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.8%
59/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.6%
112/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.3%
116/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.2%
99/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.8%
86/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.7%
31/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
20/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.8%
26/543 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
28/545 • Adverse Events, Serious Adverse Events and All-Cause mortality: Approximately 27.5 Months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER