Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (NCT NCT02617589)
NCT ID: NCT02617589
Last Updated: 2023-03-28
Results Overview
OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
560 participants
Primary outcome timeframe
up to 3 years
Results posted on
2023-03-28
Participant Flow
Participant milestones
| Measure |
Nivolumab + Radiation Therapy
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Randomization
STARTED
|
280
|
280
|
|
Randomization
COMPLETED
|
278
|
275
|
|
Randomization
NOT COMPLETED
|
2
|
5
|
|
Treatment
STARTED
|
278
|
275
|
|
Treatment
COMPLETED
|
0
|
76
|
|
Treatment
NOT COMPLETED
|
278
|
199
|
Reasons for withdrawal
| Measure |
Nivolumab + Radiation Therapy
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Randomization
Request to Discontinue Study Treatment
|
1
|
3
|
|
Randomization
Participant Withdrew Consent
|
1
|
2
|
|
Treatment
Other Reasons
|
3
|
3
|
|
Treatment
Poor/Non Compliance
|
1
|
1
|
|
Treatment
Maximum Clinical Benefit
|
0
|
2
|
|
Treatment
Participant Withdrew Consent
|
2
|
6
|
|
Treatment
Participant Request to Discontinue
|
12
|
21
|
|
Treatment
Adverse Event Unrelated to Study Drug
|
16
|
9
|
|
Treatment
Death
|
1
|
1
|
|
Treatment
Study Drug Toxicity
|
27
|
20
|
|
Treatment
Disease Progression
|
216
|
136
|
Baseline Characteristics
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Baseline characteristics by cohort
| Measure |
Nivolumab + Radiation Therapy
n=280 Participants
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
n=280 Participants
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
Total
n=560 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.5 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
57.6 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
165 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
348 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
231 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsPopulation: All Randomized Participants: All enrolled Participants who were randomized to any treatment arm.
OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
Outcome measures
| Measure |
Nivolumab + Radiation Therapy
n=280 Participants
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
n=280 Participants
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Overall Survival (OS)
|
13.40 Months
Interval 12.62 to 14.29
|
14.88 Months
Interval 13.27 to 16.13
|
SECONDARY outcome
Timeframe: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)Population: All Randomized Participants
PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Outcome measures
| Measure |
Nivolumab + Radiation Therapy
n=280 Participants
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
n=280 Participants
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Kaplan-Meier Plot of Progression Free Survival
|
6.01 Months
Interval 5.65 to 6.21
|
6.21 Months
Interval 5.98 to 6.9
|
SECONDARY outcome
Timeframe: At 24 MonthsPopulation: All Randomized Participants
The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Outcome measures
| Measure |
Nivolumab + Radiation Therapy
n=280 Participants
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
n=280 Participants
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Overall Survival Rate at 24 Months
|
10.6 Percentage of participants
Interval 7.3 to 14.6
|
21.2 Percentage of participants
Interval 16.5 to 26.3
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause (up to approximately 6 years)Population: Data was not and will never be collected
OS in all randomized participants that are tumor mutational burden high. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years)Population: Data was not and will never be collected
PFS in all randomized participants that are tumor mutational burden high. PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: From randomization to the date of death due to any cause (up to approximately 6 years)Population: All Randomized Participants
OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date (assessments were made until March 4, 2022).
Outcome measures
| Measure |
Nivolumab + Radiation Therapy
n=280 Participants
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
n=280 Participants
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Kaplan-Meier Plot of Overall Survival (OS) - Extended Collection
|
13.34 Months
Interval 12.55 to 14.16
|
14.92 Months
Interval 13.27 to 16.1
|
Adverse Events
Nivolumab + Radiation Therapy
Serious events: 206 serious events
Other events: 262 other events
Deaths: 269 deaths
Temozolomide + Radiation Therapy
Serious events: 141 serious events
Other events: 259 other events
Deaths: 253 deaths
Serious adverse events
| Measure |
Nivolumab + Radiation Therapy
n=278 participants at risk
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
n=275 participants at risk
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.9%
8/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypophysitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Retinal detachment
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Visual field defect
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
5/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
5/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Adverse event
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Gait disturbance
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
2.2%
6/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Impaired healing
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Polyserositis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
2.5%
7/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Autoimmune disorder
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Brain abscess
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Hepatitis viral
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis aseptic
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
2.2%
6/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Wound infection
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood glucose increased
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
General physical condition abnormal
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Transaminases increased
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Troponin increased
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.8%
5/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
4/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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)
Glioblastoma
|
2.2%
6/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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)
Glioblastoma multiforme
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
32.0%
89/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
20.7%
57/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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 meninges
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.2%
6/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent cancer
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
5.4%
15/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Aphasia
|
1.4%
4/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Ataxia
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Brain oedema
|
2.2%
6/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.9%
8/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebellar stroke
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
1.4%
4/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
3.2%
9/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.0%
11/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
4.0%
11/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.8%
5/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hemiparesis
|
3.2%
9/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.2%
6/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hydrocephalus
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Lethargy
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Nervous system disorder
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neurological decompensation
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neurological symptom
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Partial seizures
|
1.4%
4/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
13.3%
37/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
10.9%
30/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Apathy
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Major depression
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mood altered
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Personality change
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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 consolidation
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
2.5%
7/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
3.6%
10/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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 macular
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.72%
2/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.8%
5/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
2.2%
6/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.36%
1/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Nivolumab + Radiation Therapy
n=278 participants at risk
Nivolumab 240 mg every 2 weeks for 8 doses, then 480 mg every 4 weeks administered intravenously
|
Temozolomide + Radiation Therapy
n=275 participants at risk
Temozolomide 75 mg/m2 daily during radiation therapy, then 150 mg/m2 Days 1-5 for Cycle 1, then increased to 200 mg/m2 Days 1-5 for Cycles 2-6 administered orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
16/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.0%
11/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.5%
7/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.7%
24/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
0.36%
1/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.8%
16/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
4/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
9.5%
26/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
6.5%
18/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.73%
2/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Dry eye
|
5.0%
14/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.1%
3/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
5.8%
16/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.5%
4/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
16/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.5%
7/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
19.4%
54/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
29.1%
80/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
44/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.4%
23/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
23.7%
66/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
38.2%
105/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
12.6%
35/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
22.9%
63/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
9.0%
25/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
9.8%
27/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
44.2%
123/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
46.5%
128/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Gait disturbance
|
8.6%
24/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.5%
7/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
5.0%
14/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.7%
13/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
6.1%
17/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.5%
15/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
10.8%
30/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.8%
16/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
21/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.7%
13/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
8.3%
23/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.1%
14/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
14/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.7%
13/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
10.8%
30/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.4%
23/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
23/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
7.3%
20/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
5.4%
15/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
11.6%
32/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
1.1%
3/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
6.5%
18/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
2.9%
8/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
14.9%
41/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
7.2%
20/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
7.3%
20/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
2.2%
6/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.5%
15/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
11.9%
33/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
18.2%
50/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
15/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
3.3%
9/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
9.0%
25/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.7%
13/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
6.1%
17/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
6.2%
17/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.4%
15/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.4%
12/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Aphasia
|
10.8%
30/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
7.3%
20/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cognitive disorder
|
5.0%
14/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.4%
12/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
14.7%
41/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
6.9%
19/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
14/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.8%
16/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
41.4%
115/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
34.9%
96/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hemiparesis
|
8.6%
24/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.4%
12/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Memory impairment
|
6.8%
19/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.1%
14/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
12.6%
35/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
13.1%
36/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
6.8%
19/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.9%
8/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
6.5%
18/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
3.3%
9/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
8.3%
23/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.1%
14/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
7.9%
22/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.4%
12/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
10.4%
29/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
6.5%
18/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
7.6%
21/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.0%
11/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
26.3%
73/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
32.0%
88/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
11.2%
31/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.0%
22/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event 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
|
14.4%
40/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
6.5%
18/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
5.8%
16/278 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.4%
12/275 • All-cause mortality was assessed from the participant's randomization to their study completion (up to approximately 6 years). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 67 months).
The total number at risk for all-cause mortality represents all participants who were randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60