Trial Outcomes & Findings for Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) (NCT NCT03142334)
NCT ID: NCT03142334
Last Updated: 2024-11-13
Results Overview
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status (M0 versus M1 no evidence of disease (NED) by investigator) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1), United States (US) participant (Yes versus No) within M0 group by investigator was used to report hazard ratio (HR) and 95% confidence intervals (CIs).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
994 participants
Primary outcome timeframe
Up to approximately 42 months (database cutoff date 14 Dec 2020)
Results posted on
2024-11-13
Participant Flow
Of the 994 participants randomized in the study, 984 participants received study medication and were evaluable for safety analyses (Database cutoff date 14 Dec 2020)
Participant milestones
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
Placebo
Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
|---|---|---|
|
Overall Study
STARTED
|
496
|
498
|
|
Overall Study
Treated
|
488
|
496
|
|
Overall Study
Continuing Study Treatment
|
0
|
1
|
|
Overall Study
Completed Study Treatment
|
298
|
365
|
|
Overall Study
Discontinued Study Treatment
|
190
|
130
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
496
|
498
|
Reasons for withdrawal
| Measure |
Pembrolizumab
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
Placebo
Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
|---|---|---|
|
Overall Study
Death
|
18
|
33
|
|
Overall Study
Withdrawal by Subject
|
15
|
11
|
|
Overall Study
Ongoing on trial follow up
|
463
|
454
|
Baseline Characteristics
Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=496 Participants
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
Placebo
n=498 Participants
Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
Total
n=994 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
58.6 Years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
58.4 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
347 Participants
n=5 Participants
|
359 Participants
n=7 Participants
|
706 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
72 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
381 Participants
n=5 Participants
|
394 Participants
n=7 Participants
|
775 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
372 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
749 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 42 months (database cutoff date 14 Dec 2020)Population: All randomized participants
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status (M0 versus M1 no evidence of disease (NED) by investigator) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1), United States (US) participant (Yes versus No) within M0 group by investigator was used to report hazard ratio (HR) and 95% confidence intervals (CIs).
Outcome measures
| Measure |
Pembrolizumab
n=496 Participants
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
Placebo
n=498 Participants
Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
|---|---|---|
|
Disease-free Survival (DFS) as Assessed by the Investigator
|
NA Months
NA = Median, lower and upper limit of 95% CIs for DFS was not reportable at the time of last disease assessment due to insufficient number of participants with events by the time of the data cutoff (14-Dec-2020).
|
NA Months
NA = Median, lower and upper limit of 95% CIs for DFS was not reportable at the time of last disease assessment due to insufficient number of participants with events by the time of the data cutoff (14-Dec-2020).
|
SECONDARY outcome
Timeframe: Up to approximately 72 monthsOS was defined as the time from randomization to death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants are monitored for the occurrence of nonserious AEs for up to 30 days after last dose of study treatment and of serious AEs for up to 90 days after last dose of study treatment. The number of participants who experience an AE will be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 12 monthsAn AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinue study treatment due to an AE will be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 72 monthsDRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 72 monthsDRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 72 monthsEFS is defined as time from randomization to the first documented local recurrence or occurrence of distant kidney cancer metastasis(es) among participants which by BICR were considered disease-free at baseline (M0/M1 NED); or disease progression among participants which by BICR were considered to have baseline disease (M1), or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 72 monthsDFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is \<1, PD-L1 expression status is negative.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 72 monthsOS is defined as the time from randomization to death due to any cause. The PD-L1 expression status is based on combined positive score (CPS). If CPS is ≥ 1, PD-L1 expression status is positive and if the CPS is \<1, PD-L1 expression status is negative.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 52The QLQ-C30 quality of life (QOL) questionnaire contains 5 functioning scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain) and single symptom items (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Items are scored on a 4-point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much). The QLQC30 also contains 2 global health status scales that use 7-point scale scoring (1=very poor and 7=excellent). The change from baseline in the 2-item global health status/QOL life scale (range: 2-14) will be presented, with a higher score representing a higher QOL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 52The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer over the previous 7 days. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status. The change from baseline in the FKSI-DRS index score will be presented.
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab
Serious events: 100 serious events
Other events: 436 other events
Deaths: 18 deaths
Placebo
Serious events: 56 serious events
Other events: 393 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=488 participants at risk
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
Placebo
n=496 participants at risk
Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.40%
2/496 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Bundle branch block left
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
3/488 • Number of events 3 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocarditis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pleuropericarditis
|
0.20%
1/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.2%
6/488 • Number of events 6 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hypophysitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Thyroiditis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
1.0%
5/488 • Number of events 5 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Anorectal infection
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Encephalitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Infection
|
0.20%
1/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Meningitis aseptic
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.2%
6/488 • Number of events 6 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic shock
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.40%
2/496 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral infection
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.0%
5/488 • Number of events 6 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.82%
4/488 • Number of events 4 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.41%
2/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.60%
3/496 • Number of events 3 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma metastatic
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary myelofibrosis
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.40%
2/496 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.20%
1/488 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.40%
2/496 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.40%
2/496 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Tension headache
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
6/488 • Number of events 6 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Bladder mass
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.40%
2/496 • Number of events 3 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.40%
2/496 • Number of events 2 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.61%
3/488 • Number of events 3 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.60%
3/496 • Number of events 3 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Lichenification
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Essential hypertension
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Giant cell arteritis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/488 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Vasculitis
|
0.20%
1/488 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.00%
0/496 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Pembrolizumab
n=488 participants at risk
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
Placebo
n=496 participants at risk
Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
|
|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
11.5%
56/488 • Number of events 58 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
0.20%
1/496 • Number of events 1 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
21.1%
103/488 • Number of events 111 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.6%
18/496 • Number of events 20 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
36/488 • Number of events 54 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
7.9%
39/496 • Number of events 50 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
7.2%
35/488 • Number of events 39 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
8.1%
40/496 • Number of events 42 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.2%
123/488 • Number of events 195 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
22.4%
111/496 • Number of events 171 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
33/488 • Number of events 37 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
1.0%
5/496 • Number of events 5 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
16.4%
80/488 • Number of events 105 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
9.7%
48/496 • Number of events 61 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
39/488 • Number of events 44 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.6%
28/496 • Number of events 31 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
10.2%
50/488 • Number of events 85 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
7.3%
36/496 • Number of events 50 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
29.7%
145/488 • Number of events 180 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
24.2%
120/496 • Number of events 156 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
5.1%
25/488 • Number of events 26 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.2%
21/496 • Number of events 24 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
4.3%
21/488 • Number of events 26 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.4%
27/496 • Number of events 30 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
6.4%
31/488 • Number of events 31 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.4%
22/496 • Number of events 24 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
28/488 • Number of events 33 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
8.5%
42/496 • Number of events 47 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
27/488 • Number of events 32 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.8%
24/496 • Number of events 27 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
29/488 • Number of events 36 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.0%
20/496 • Number of events 30 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.2%
35/488 • Number of events 42 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.4%
17/496 • Number of events 23 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
36/488 • Number of events 40 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.0%
10/496 • Number of events 14 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
10.2%
50/488 • Number of events 59 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
8.5%
42/496 • Number of events 52 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.0%
34/488 • Number of events 34 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
2.0%
10/496 • Number of events 10 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
28/488 • Number of events 36 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
3.4%
17/496 • Number of events 20 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.1%
108/488 • Number of events 159 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
18.8%
93/496 • Number of events 123 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
49/488 • Number of events 56 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
12.7%
63/496 • Number of events 70 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
46/488 • Number of events 60 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
6.5%
32/496 • Number of events 38 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.2%
35/488 • Number of events 41 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.0%
25/496 • Number of events 30 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
8.0%
39/488 • Number of events 47 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.4%
27/496 • Number of events 32 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
14.1%
69/488 • Number of events 92 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
12.5%
62/496 • Number of events 91 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.3%
26/488 • Number of events 27 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.8%
29/496 • Number of events 32 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.6%
76/488 • Number of events 90 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
10.1%
50/496 • Number of events 56 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
30/488 • Number of events 32 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
5.4%
27/496 • Number of events 38 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
26/488 • Number of events 30 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
4.4%
22/496 • Number of events 22 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.7%
111/488 • Number of events 148 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
13.1%
65/496 • Number of events 75 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.1%
98/488 • Number of events 151 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
10.7%
53/496 • Number of events 83 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
7.8%
38/488 • Number of events 46 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
7.9%
39/496 • Number of events 43 • Up to approximately 43 months (Database cutoff date 14 Dec 2020).
All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER