Trial Outcomes & Findings for A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors (NCT NCT04567615)
NCT ID: NCT04567615
Last Updated: 2026-01-08
Results Overview
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
266 participants
Primary outcome timeframe
From randomization to primary completion date (Approximately 29.5 Months)
Results posted on
2026-01-08
Participant Flow
266 Participants Randomized, 264 Treated
Participant milestones
| Measure |
Treatment A
Nivolumab 480mg Q4W
|
Treatment B
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Randomization
STARTED
|
128
|
114
|
24
|
|
Randomization
COMPLETED
|
127
|
113
|
24
|
|
Randomization
NOT COMPLETED
|
1
|
1
|
0
|
|
Treatment Period
STARTED
|
127
|
113
|
24
|
|
Treatment Period
COMPLETED
|
3
|
1
|
0
|
|
Treatment Period
NOT COMPLETED
|
124
|
112
|
24
|
Reasons for withdrawal
| Measure |
Treatment A
Nivolumab 480mg Q4W
|
Treatment B
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Randomization
Participant withdrew consent
|
1
|
0
|
0
|
|
Randomization
Adverse event unrelated to study drug
|
0
|
1
|
0
|
|
Treatment Period
Participant Withdrew Consent
|
2
|
5
|
1
|
|
Treatment Period
Death
|
1
|
2
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Treatment Period
Participant No Longer Meets Study Criteria
|
0
|
1
|
0
|
|
Treatment Period
Disease Progression
|
85
|
63
|
16
|
|
Treatment Period
Study Drug Toxicity
|
3
|
10
|
4
|
|
Treatment Period
Adverse Event Unrelated to Study Drug
|
11
|
6
|
1
|
|
Treatment Period
Other Reasons
|
1
|
2
|
0
|
|
Treatment Period
Still On-going Treatment
|
21
|
22
|
2
|
Baseline Characteristics
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors
Baseline characteristics by cohort
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 Years
STANDARD_DEVIATION 10.4 • n=18 Participants
|
63.3 Years
STANDARD_DEVIATION 11.2 • n=17 Participants
|
68.1 Years
STANDARD_DEVIATION 10.9 • n=35 Participants
|
64.1 Years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=18 Participants
|
21 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
46 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=18 Participants
|
93 Participants
n=17 Participants
|
22 Participants
n=35 Participants
|
220 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=18 Participants
|
16 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
30 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=18 Participants
|
47 Participants
n=17 Participants
|
15 Participants
n=35 Participants
|
127 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=18 Participants
|
51 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
109 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=18 Participants
|
54 Participants
n=17 Participants
|
12 Participants
n=35 Participants
|
127 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=18 Participants
|
19 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
49 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
8 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
16 Participants
n=18 Participants
|
16 Participants
n=17 Participants
|
4 Participants
n=35 Participants
|
36 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
7 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
3 Participants
n=35 Participants
|
14 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Malay
|
0 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian Other
|
6 Participants
n=18 Participants
|
8 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
16 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Randomized Participants
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
Outcome measures
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Objective Response Rate(ORR) Assessed by BICR
|
13.3 Percentage
Interval 7.9 to 20.4
|
10.5 Percentage
Interval 5.6 to 17.7
|
12.5 Percentage
Interval 2.7 to 32.4
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Randomized Participants
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Outcome measures
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Disease Control Rate Assessed by BICR
|
44.5 Percentage
Interval 35.7 to 53.6
|
44.7 Percentage
Interval 35.4 to 54.3
|
33.3 Percentage
Interval 15.6 to 55.3
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Confirmed Responders
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
Outcome measures
| Measure |
Treatment A
n=17 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=12 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=3 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Duration of Response Assessed by BICR
|
5.82 Months
Interval 5.55 to
insufficient number of participants with events to calculate Median.
|
NA Months
Interval 5.32 to
insufficient number of participants with events to calculate Median and Upper Limit Number.
|
NA Months
Interval 7.39 to
insufficient number of participants with events to calculate Median and Upper Limit Numbe.
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Randomized Subjects
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
Outcome measures
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Progression Free Survival(PFS) Assessed by BICR
|
2.00 Months
Interval 1.91 to 3.75
|
2.00 Months
Interval 1.87 to 3.71
|
1.94 Months
Interval 1.74 to 3.71
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Randomized Participants
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
Outcome measures
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Objective Response Rate Assessed by Investigator
|
14.1 Percentage
Interval 8.6 to 21.3
|
13.2 Percentage
Interval 7.6 to 20.8
|
20.8 Percentage
Interval 7.1 to 42.2
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Randomized Participants
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Outcome measures
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Disease Control Rate Assessed by Investigator
|
48.4 Percentage
Interval 39.5 to 57.4
|
50.9 Percentage
Interval 41.3 to 60.4
|
41.7 Percentage
Interval 22.1 to 63.4
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Confirmed Responders
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=15 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=5 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Duration of Response Assessed by Investigator
|
10.94 Months
Interval 4.63 to
insufficient number of participants with events to calculate Median. to calculate Upper Limit Number.
|
NA Months
Interval 5.55 to
insufficient number of participants with events to calculate Median. to calculate Median and Upper Limit Number.
|
12.42 Months
Interval 3.61 to
insufficient number of participants with events to calculate Median. to calculate Upper Limit Number.
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Randomized Subjects
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
Outcome measures
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Progression Free Survival(PFS) Assessed by Investigator
|
3.32 Months
Interval 2.0 to 4.01
|
3.65 Months
Interval 1.97 to 4.3
|
1.94 Months
Interval 1.68 to 3.75
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Randomized Subjects
Overall survival (OS) is defined as the time from randomization to the date of death from any cause. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.
Outcome measures
| Measure |
Treatment A
n=128 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=114 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Overall Survival (OS)
|
12.68 Months
Interval 9.4 to 18.76
|
12.19 Months
Interval 9.49 to 14.52
|
8.21 Months
Interval 4.76 to 16.92
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.Population: All Treated Participants
Number of participants with an Adverse Event. An Adverse Event is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Treatment A
n=127 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=113 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
119 Participants
|
108 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.Population: All Treated Participants
Number of participants with Serious Adverse Events A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Outcome measures
| Measure |
Treatment A
n=127 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=113 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
43 Participants
|
46 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.Population: All Treated Participants
Number of participants with Adverse Events Leading to Discontinuation
Outcome measures
| Measure |
Treatment A
n=127 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=113 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
|
13 Participants
|
14 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months)Population: All Treated Participants
Number of participants who died.
Outcome measures
| Measure |
Treatment A
n=127 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=113 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Death Summary
|
67 Participants
|
60 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.Population: All Treated Participants
Number of participants with clinical laboratory abnormalities in specific liver tests
Outcome measures
| Measure |
Treatment A
n=127 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=113 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN >2XULN WITHIN 30 DAYS
|
14 Participants
|
10 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
TOTAL BILIRUBIN > 2XULN
|
17 Participants
|
14 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
ALT OR AST> 5XULN
|
25 Participants
|
41 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
ALT OR AST> 10XULN
|
7 Participants
|
16 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.Population: All Treated Participants with at least on on-treatment TSH measurement
Number of participants with clinical laboratory abnormalities in thyroid tests
Outcome measures
| Measure |
Treatment A
n=117 Participants
Nivolumab 480mg Q4W
|
Treatment B
n=99 Participants
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=18 Participants
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
TSH > ULN
|
38 Participants
|
42 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
TSH > ULN WITH TSH ≤ ULN AT BASELINE
|
14 Participants
|
18 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
TSH <LLN WITH TSH ≥ LLN AT BASELINE
|
16 Participants
|
26 Participants
|
2 Participants
|
Adverse Events
Treatment A
Serious events: 65 serious events
Other events: 104 other events
Deaths: 68 deaths
Treatment B
Serious events: 65 serious events
Other events: 102 other events
Deaths: 60 deaths
Treatment C
Serious events: 20 serious events
Other events: 22 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Treatment A
n=127 participants at risk
Nivolumab 480mg Q4W
|
Treatment B
n=113 participants at risk
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 participants at risk
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Heart valve incompetence
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Tachycardia
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
2.4%
3/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haematemesis
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Adverse event
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest discomfort
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Biliary colic
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholangitis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic failure
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatorenal failure
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Jaundice
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abdominal wall abscess
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Anal abscess
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bacteraemia
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
2.4%
3/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile infection
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Groin abscess
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Liver abscess
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
3.9%
5/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia aspiration
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urosepsis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatine phosphokinase increased
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
General physical condition abnormal
|
2.4%
3/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Haemoglobin decreased
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin I increased
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin T increased
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin increased
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Necrotising myositis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
22.8%
29/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.2%
24/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
6/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral infarction
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hydrocephalus
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Immune-mediated myasthenia gravis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Monoplegia
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Spinal cord compression
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Agitation
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Completed suicide
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.5%
4/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Shock haemorrhagic
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Treatment A
n=127 participants at risk
Nivolumab 480mg Q4W
|
Treatment B
n=113 participants at risk
Nivolumab 480mg Q4W + Relatlimab 480mg Q4W
|
Treatment C
n=24 participants at risk
Nivolumab 480mg Q4W + Relatlimab 960mg Q4W
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.5%
21/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.2%
16/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
6/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.5%
4/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
3/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
7/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
4/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.0%
9/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.79%
1/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.0%
9/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
3.9%
5/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.3%
15/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
7.9%
10/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.2%
16/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.7%
6/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
5/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
4.7%
6/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
11/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
4/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
9.4%
12/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
12/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
11/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.7%
20/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
6/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
6/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
4.7%
6/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.0%
17/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
4/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.2%
7/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
12.6%
16/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.0%
9/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.2%
7/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
12.6%
16/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.2%
16/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
13.4%
17/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.7%
20/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.0%
9/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
6/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
5.5%
7/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.4%
14/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.88%
1/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
3.1%
4/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
8/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
16.5%
21/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.9%
27/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Amylase increased
|
3.9%
5/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.5%
13/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
26.0%
33/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.2%
33/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
6/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
11.0%
14/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.9%
18/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
7.1%
9/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
10/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lipase increased
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
12/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
3.1%
4/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
10/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin increased
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
6/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.9%
10/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.3%
15/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
4/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
8/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.5%
4/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.7%
6/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
8/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.0%
9/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
5/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.7%
11/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
2/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
14/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.5%
13/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.9%
5/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
8/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.2%
1/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
5.5%
7/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
5/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
1.6%
2/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
5/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Proteinuria
|
4.7%
6/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
8/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
7/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
8/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
6/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.4%
5/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
3/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.9%
24/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.2%
16/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
4/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.3%
8/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
12/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
4/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
3.9%
5/127 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
6/113 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/24 • Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: 1-855-907-3286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER