Trial Outcomes & Findings for A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer (NCT NCT04025879)
NCT ID: NCT04025879
Last Updated: 2025-10-16
Results Overview
The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
461 participants
Primary outcome timeframe
From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
Results posted on
2025-10-16
Participant Flow
Participant milestones
| Measure |
Nivolumab + SOC Chemotherapy
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
Randomization
STARTED
|
229
|
232
|
|
Randomization
COMPLETED
|
228
|
230
|
|
Randomization
NOT COMPLETED
|
1
|
2
|
|
Treatment
STARTED
|
228
|
230
|
|
Treatment
Neoadjuvant Treatment
|
228
|
230
|
|
Treatment
Adjuvant Treatment
|
142
|
152
|
|
Treatment
COMPLETED
|
85
|
92
|
|
Treatment
NOT COMPLETED
|
143
|
138
|
Reasons for withdrawal
| Measure |
Nivolumab + SOC Chemotherapy
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
Randomization
Participant withdrew consent
|
0
|
1
|
|
Randomization
Participant no longer met study criteria
|
1
|
1
|
|
Treatment
Ongoing treatment
|
10
|
8
|
|
Treatment
Disease progression/recurrence
|
36
|
72
|
|
Treatment
Study drug toxicity
|
36
|
13
|
|
Treatment
Death
|
2
|
0
|
|
Treatment
Adverse event unrelated to study drug
|
21
|
14
|
|
Treatment
Participant request to discontinue study treatment
|
16
|
8
|
|
Treatment
Participant withdrew consent
|
1
|
3
|
|
Treatment
Participant no longer meets study criteria
|
3
|
2
|
|
Treatment
Lost to Follow-up
|
1
|
0
|
|
Treatment
Other reasons
|
15
|
17
|
|
Treatment
Administrative reason by sponsor
|
0
|
1
|
|
Treatment
Not reported
|
2
|
0
|
Baseline Characteristics
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Nivolumab + SOC Chemotherapy
n=229 Participants
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=232 Participants
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
127 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
64.6 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
64.4 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
92 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
116 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
155 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)Population: All randomized participants
The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
Outcome measures
| Measure |
Nivolumab + SOC Chemotherapy
n=229 Participants
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=232 Participants
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
Event-Free Survival (EFS) by BICR
|
NA Months
Interval 28.94 to
Insufficient number of participants with events
|
18.43 Months
Interval 13.63 to 28.06
|
SECONDARY outcome
Timeframe: From randomization and the date of death due to any cause.OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization up to approximately 44 monthsPopulation: All randomized participants
Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
Outcome measures
| Measure |
Nivolumab + SOC Chemotherapy
n=229 Participants
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=232 Participants
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
Pathologic Complete Response (pCR) Rate
|
25.3 Percentage of Participants
Interval 19.8 to 31.5
|
4.7 Percentage of Participants
Interval 2.4 to 8.3
|
SECONDARY outcome
Timeframe: From randomization up to approximately 44 monthsPopulation: All randomized participants
Major pathological response (MPR) rate is defined as the percentage of randomized participants with ≤10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
Outcome measures
| Measure |
Nivolumab + SOC Chemotherapy
n=229 Participants
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=232 Participants
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
Major Pathological Response (MPR) Rate
|
35.4 Percentage of participants
Interval 29.2 to 41.9
|
12.1 Percentage of participants
Interval 8.2 to 17.0
|
SECONDARY outcome
Timeframe: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)Population: All participants who received at least one dose of study medication in neoadjuvant or adjuvant setting.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Nivolumab + SOC Chemotherapy
n=228 Participants
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=230 Participants
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
The Number of Participants With Adverse Events (AEs)
|
222 Participants
|
225 Participants
|
SECONDARY outcome
Timeframe: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)Population: All participants who received at least one dose of study medication in neoadjuvant or adjuvant setting.
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Outcome measures
| Measure |
Nivolumab + SOC Chemotherapy
n=228 Participants
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=230 Participants
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
The Number of Participants With Serious Adverse Events (SAEs)
|
96 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)Population: All participants who received at least one dose of study medication in neoadjuvant or adjuvant setting.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.
Outcome measures
| Measure |
Nivolumab + SOC Chemotherapy
n=228 Participants
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=230 Participants
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
The Number of Participants With Select Adverse Events (AEs)
Gastrointestinal Event
|
37 Participants
|
37 Participants
|
|
The Number of Participants With Select Adverse Events (AEs)
Hepatic Event
|
46 Participants
|
31 Participants
|
|
The Number of Participants With Select Adverse Events (AEs)
Pulmonary Event
|
17 Participants
|
8 Participants
|
|
The Number of Participants With Select Adverse Events (AEs)
Renal Event
|
34 Participants
|
18 Participants
|
|
The Number of Participants With Select Adverse Events (AEs)
Skin Event
|
71 Participants
|
53 Participants
|
|
The Number of Participants With Select Adverse Events (AEs)
Hypersensitivity/Infusion Reaction Event
|
15 Participants
|
14 Participants
|
|
The Number of Participants With Select Adverse Events (AEs)
Endocrine Event
|
42 Participants
|
13 Participants
|
Adverse Events
Nivolumab + SOC Chemotherapy
Serious events: 109 serious events
Other events: 214 other events
Deaths: 40 deaths
Placebo + SOC Chemotherapy
Serious events: 83 serious events
Other events: 212 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
Nivolumab + SOC Chemotherapy
n=228 participants at risk
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=230 participants at risk
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
4/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Acute myocardial infarction
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina pectoris
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
4/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac tamponade
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocarditis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal disorder
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Cataract
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
1.8%
4/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Duodenitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Enterocolitis
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric polyps
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastritis
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haematochezia
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Melaena
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest pain
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Death
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Dehiscence
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Inflammation
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Sudden death
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.3%
3/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Anaphylactic reaction
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Hypersensitivity
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Aspergillus infection
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
1.8%
4/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19 pneumonia
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile colitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Empyema
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Encephalomyelitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Enterocolitis infectious
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpes zoster
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpetic radiculopathy
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infection
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Liver abscess
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Myelitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.3%
3/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
3.9%
9/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
10/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia viral
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Post procedural infection
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Post procedural sepsis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Prostate infection
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pulmonary sepsis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Rectal abscess
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
1.8%
4/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Systemic infection
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Wound infection
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood potassium decreased
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
C-reactive protein increased
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
1.3%
3/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.3%
3/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
6/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paget's disease of nipple
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Carotid artery stenosis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebrovascular accident
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Encephalopathy
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Facial paralysis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Quadriplegia
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
5/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Nephritis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.2%
5/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
3/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.3%
3/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
5/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
4/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.87%
2/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.88%
2/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.3%
3/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Embolism
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Embolism arterial
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.43%
1/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Shock haemorrhagic
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Vascular compression
|
0.44%
1/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Nivolumab + SOC Chemotherapy
n=228 participants at risk
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
|
Placebo + SOC Chemotherapy
n=230 participants at risk
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.8%
93/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
31.7%
73/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.1%
7/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
15/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.1%
23/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.6%
22/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
5.3%
12/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
5/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
12.3%
28/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
4/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
12/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
15/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
4/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.2%
12/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
31.6%
72/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.3%
65/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
16.2%
37/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.7%
36/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.9%
9/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.2%
12/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
29.4%
67/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.9%
78/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
26/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.3%
26/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
10.5%
24/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
25/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest pain
|
4.8%
11/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.2%
12/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
29.4%
67/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.2%
58/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Malaise
|
6.1%
14/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.0%
16/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
3.1%
7/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
13/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
7.0%
16/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.9%
9/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
7.0%
16/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
10/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
11.0%
25/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
15/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
12.3%
28/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.6%
22/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
6.6%
15/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
11/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
5/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.1%
14/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.3%
12/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.1%
14/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.3%
12/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
6/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
26/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
13/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
15/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.1%
14/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
6.6%
15/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.0%
7/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
12.7%
29/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.1%
14/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
14.9%
34/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
20/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
8.8%
20/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
17/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
6.6%
15/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.8%
18/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
12.7%
29/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
10/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.7%
45/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
46/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.6%
22/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.2%
12/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
12/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
19/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.0%
16/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.5%
8/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.7%
45/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.3%
42/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
20/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.8%
18/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.9%
18/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
25/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
9/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.1%
14/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
7.9%
18/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.5%
8/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysgeusia
|
3.9%
9/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.1%
14/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
8.3%
19/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.8%
18/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
11.0%
25/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
25/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.2%
30/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
23/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
7.0%
16/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.8%
18/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.4%
51/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.9%
48/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.1%
39/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.7%
36/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.3%
19/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
11/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.9%
59/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
27.8%
64/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
15/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
4/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
32/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.0%
16/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
26/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.7%
27/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
13/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
5/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
5.3%
12/228 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
6/230 • All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER