Trial Outcomes & Findings for A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma (NCT NCT02714218)
NCT ID: NCT02714218
Last Updated: 2022-06-24
Results Overview
The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
387 participants
Primary outcome timeframe
From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)
Results posted on
2022-06-24
Participant Flow
387 participants were randomized, 385 were treated. Cohort C/N6I1 assessed for exploratory outcome measures not being reported in the Outcome Measures module. Safety data included with AE data.
Participant milestones
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg
nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
|
|---|---|---|---|
|
Pre-Treatment Period
STARTED
|
180
|
180
|
27
|
|
Pre-Treatment Period
COMPLETED
|
180
|
178
|
27
|
|
Pre-Treatment Period
NOT COMPLETED
|
0
|
2
|
0
|
|
Treatment Period
STARTED
|
180
|
178
|
27
|
|
Treatment Period
COMPLETED
|
6
|
2
|
2
|
|
Treatment Period
NOT COMPLETED
|
174
|
176
|
25
|
Reasons for withdrawal
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg
nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
|
|---|---|---|---|
|
Pre-Treatment Period
Participant no longer meets study criteria
|
0
|
1
|
0
|
|
Pre-Treatment Period
Other reasons
|
0
|
1
|
0
|
|
Treatment Period
Disease Progression
|
55
|
52
|
14
|
|
Treatment Period
Study drug toxicity
|
46
|
70
|
6
|
|
Treatment Period
Adverse event unrelated to study drug
|
13
|
6
|
1
|
|
Treatment Period
Request to discontinue treatment
|
1
|
4
|
1
|
|
Treatment Period
Participant withdrew consent
|
2
|
2
|
0
|
|
Treatment Period
Maximum clinical benefit
|
4
|
2
|
0
|
|
Treatment Period
Administrative reason by sponsor
|
2
|
1
|
0
|
|
Treatment Period
Other reasons
|
6
|
6
|
0
|
|
Treatment Period
Completed treatment as per protocol
|
36
|
27
|
3
|
|
Treatment Period
Not reported
|
9
|
6
|
0
|
Baseline Characteristics
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=180 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg
n=27 Participants
nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65
|
115 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
Age, Customized
>= 65 AND < 75
|
48 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Age, Customized
>= 75
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
174 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
367 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)Population: All treated participants in cohorts A and B
The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=178 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)
|
32.8 Percentage of participants
Interval 26.0 to 40.2
|
45.5 Percentage of participants
Interval 38.0 to 53.1
|
SECONDARY outcome
Timeframe: From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)Population: All treated participants in cohorts A and B
The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of progression per RECIST 1.1 or the date of subsequent anticancer therapy, whichever occurred first. For subjects without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Tumor assessments are scheduled at Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=178 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Objective Response Rate (ORR)
|
47.8 Percentage of participants
Interval 40.3 to 55.3
|
53.4 Percentage of participants
Interval 45.8 to 60.9
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)Population: All treated participants in cohorts A and B
The time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=178 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 43.73 to
Insufficient number of participants with events
|
NA Months
Interval 40.84 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)Population: All treated participants in cohorts A and B
The time between the date of randomization and the first date of documented progression, determined by the investigator, 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. Those who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants without on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. Based on Kaplan-Meier Estimates. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=178 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Progression Free Survival (PFS)
|
10.18 Months
Interval 6.24 to 21.91
|
9.99 Months
Interval 6.28 to 28.88
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Physical Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 7
|
-2.1 Scores on a scale
Standard Deviation 16.2
|
-4.9 Scores on a scale
Standard Deviation 16.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 16
|
-1.9 Scores on a scale
Standard Deviation 15.3
|
-2.7 Scores on a scale
Standard Deviation 15.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 20
|
-1.4 Scores on a scale
Standard Deviation 10.7
|
-2.7 Scores on a scale
Standard Deviation 13.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 24
|
-5.1 Scores on a scale
Standard Deviation 15.6
|
-5.7 Scores on a scale
Standard Deviation 13.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 28
|
-2.5 Scores on a scale
Standard Deviation 15.0
|
-0.7 Scores on a scale
Standard Deviation 14.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 32
|
-3.3 Scores on a scale
Standard Deviation 16.5
|
-3.5 Scores on a scale
Standard Deviation 15.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 36
|
-4.0 Scores on a scale
Standard Deviation 19.1
|
-2.9 Scores on a scale
Standard Deviation 14.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
Week 40
|
-3.3 Scores on a scale
Standard Deviation 17.3
|
-3.4 Scores on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Role Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 7
|
-2.5 Scores on a scale
Standard Deviation 28.3
|
-8.8 Scores on a scale
Standard Deviation 25.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 16
|
-6.6 Scores on a scale
Standard Deviation 30.3
|
2.1 Scores on a scale
Standard Deviation 25.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 20
|
-1.8 Scores on a scale
Standard Deviation 19.9
|
-5.2 Scores on a scale
Standard Deviation 25.2
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 24
|
-3.9 Scores on a scale
Standard Deviation 19.9
|
-9.8 Scores on a scale
Standard Deviation 29.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 28
|
-0.9 Scores on a scale
Standard Deviation 23.4
|
-1.3 Scores on a scale
Standard Deviation 26.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 32
|
-3.6 Scores on a scale
Standard Deviation 25.1
|
-2.2 Scores on a scale
Standard Deviation 29.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 36
|
-3.9 Scores on a scale
Standard Deviation 26.4
|
-2.9 Scores on a scale
Standard Deviation 30.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
Week 40
|
-4.0 Scores on a scale
Standard Deviation 26.7
|
-5.2 Scores on a scale
Standard Deviation 34.2
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Emotional Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 7
|
4.5 Scores on a scale
Standard Deviation 17.9
|
4.4 Scores on a scale
Standard Deviation 16.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 16
|
0.0 Scores on a scale
Standard Deviation 21.7
|
6.6 Scores on a scale
Standard Deviation 20.1
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 20
|
3.9 Scores on a scale
Standard Deviation 18.0
|
4.5 Scores on a scale
Standard Deviation 18.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 24
|
3.4 Scores on a scale
Standard Deviation 18.4
|
2.6 Scores on a scale
Standard Deviation 23.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 28
|
5.9 Scores on a scale
Standard Deviation 19.5
|
5.6 Scores on a scale
Standard Deviation 22.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 32
|
5.5 Scores on a scale
Standard Deviation 17.3
|
5.1 Scores on a scale
Standard Deviation 21.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 36
|
3.0 Scores on a scale
Standard Deviation 17.0
|
4.7 Scores on a scale
Standard Deviation 22.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
Week 40
|
4.5 Scores on a scale
Standard Deviation 21.4
|
5.4 Scores on a scale
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Cognitive Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 24
|
-2.7 Scores on a scale
Standard Deviation 15.0
|
-3.4 Scores on a scale
Standard Deviation 14.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 7
|
-3.4 Scores on a scale
Standard Deviation 15.0
|
-1.9 Scores on a scale
Standard Deviation 16.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 16
|
-2.6 Scores on a scale
Standard Deviation 14.4
|
-5.9 Scores on a scale
Standard Deviation 22.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 20
|
-1.9 Scores on a scale
Standard Deviation 16.9
|
-6.0 Scores on a scale
Standard Deviation 17.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 28
|
-3.7 Scores on a scale
Standard Deviation 17.7
|
-3.7 Scores on a scale
Standard Deviation 16.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 32
|
-1.5 Scores on a scale
Standard Deviation 16.6
|
-4.8 Scores on a scale
Standard Deviation 16.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 36
|
-3.1 Scores on a scale
Standard Deviation 18.5
|
-8.8 Scores on a scale
Standard Deviation 20.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
Week 40
|
-2.6 Scores on a scale
Standard Deviation 20.3
|
-4.4 Scores on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Social Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=120 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=110 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 36
|
0.5 Scores on a scale
Standard Deviation 20.4
|
0.3 Scores on a scale
Standard Deviation 22.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 7
|
-3.1 Scores on a scale
Standard Deviation 22.8
|
-6.1 Scores on a scale
Standard Deviation 25.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 16
|
-6.3 Scores on a scale
Standard Deviation 23.5
|
-2.8 Scores on a scale
Standard Deviation 26.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 20
|
-4.6 Scores on a scale
Standard Deviation 21.0
|
-3.2 Scores on a scale
Standard Deviation 20.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 24
|
-1.6 Scores on a scale
Standard Deviation 17.2
|
-3.7 Scores on a scale
Standard Deviation 20.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 28
|
1.4 Scores on a scale
Standard Deviation 18.1
|
-1.0 Scores on a scale
Standard Deviation 22.2
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 32
|
0.3 Scores on a scale
Standard Deviation 17.6
|
-1.0 Scores on a scale
Standard Deviation 19.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
Week 40
|
1.1 Scores on a scale
Standard Deviation 22.0
|
-4.1 Scores on a scale
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=120 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=111 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 7
|
0.5 Scores on a scale
Standard Deviation 22.9
|
-0.5 Scores on a scale
Standard Deviation 19.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 16
|
0.0 Scores on a scale
Standard Deviation 18.5
|
5.0 Scores on a scale
Standard Deviation 24.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 20
|
-1.5 Scores on a scale
Standard Deviation 19.9
|
0.0 Scores on a scale
Standard Deviation 19.1
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 24
|
-0.5 Scores on a scale
Standard Deviation 16.1
|
-1.6 Scores on a scale
Standard Deviation 24.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 28
|
0.7 Scores on a scale
Standard Deviation 21.1
|
6.3 Scores on a scale
Standard Deviation 23.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 32
|
-0.5 Scores on a scale
Standard Deviation 23.2
|
5.4 Scores on a scale
Standard Deviation 23.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 36
|
-2.9 Scores on a scale
Standard Deviation 21.8
|
2.6 Scores on a scale
Standard Deviation 25.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
Week 40
|
-0.8 Scores on a scale
Standard Deviation 22.2
|
3.7 Scores on a scale
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Dyspnea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 7
|
4.4 Scores on a scale
Standard Deviation 21.5
|
6.3 Scores on a scale
Standard Deviation 23.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 16
|
5.8 Scores on a scale
Standard Deviation 22.0
|
2.1 Scores on a scale
Standard Deviation 21.1
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 20
|
2.7 Scores on a scale
Standard Deviation 22.7
|
2.3 Scores on a scale
Standard Deviation 22.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 24
|
2.3 Scores on a scale
Standard Deviation 19.5
|
2.3 Scores on a scale
Standard Deviation 22.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 28
|
3.2 Scores on a scale
Standard Deviation 25.7
|
0.0 Scores on a scale
Standard Deviation 23.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 32
|
2.6 Scores on a scale
Standard Deviation 23.1
|
2.6 Scores on a scale
Standard Deviation 22.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 36
|
4.2 Scores on a scale
Standard Deviation 21.8
|
0.0 Scores on a scale
Standard Deviation 21.1
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
Week 40
|
3.7 Scores on a scale
Standard Deviation 22.5
|
2.2 Scores on a scale
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Insomnia sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=120 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 7
|
0.6 Scores on a scale
Standard Deviation 28.7
|
-1.5 Scores on a scale
Standard Deviation 30.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 16
|
-0.5 Scores on a scale
Standard Deviation 28.0
|
-2.8 Scores on a scale
Standard Deviation 29.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 20
|
-0.9 Scores on a scale
Standard Deviation 28.5
|
-6.3 Scores on a scale
Standard Deviation 28.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 24
|
2.3 Scores on a scale
Standard Deviation 28.0
|
-7.5 Scores on a scale
Standard Deviation 26.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 28
|
0.9 Scores on a scale
Standard Deviation 25.6
|
-7.3 Scores on a scale
Standard Deviation 28.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 32
|
-3.1 Scores on a scale
Standard Deviation 24.1
|
-10.5 Scores on a scale
Standard Deviation 29.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 36
|
0.5 Scores on a scale
Standard Deviation 24.8
|
-8.5 Scores on a scale
Standard Deviation 30.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
Week 40
|
-1.1 Scores on a scale
Standard Deviation 18.9
|
-14.1 Scores on a scale
Standard Deviation 31.4
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Appetite loss sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 7
|
3.0 Scores on a scale
Standard Deviation 24.7
|
4.8 Scores on a scale
Standard Deviation 28.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 16
|
2.1 Scores on a scale
Standard Deviation 28.6
|
-1.4 Scores on a scale
Standard Deviation 31.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 20
|
1.4 Scores on a scale
Standard Deviation 21.8
|
-3.5 Scores on a scale
Standard Deviation 25.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 24
|
-0.9 Scores on a scale
Standard Deviation 22.9
|
-2.9 Scores on a scale
Standard Deviation 32.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 28
|
-0.9 Scores on a scale
Standard Deviation 23.0
|
-7.3 Scores on a scale
Standard Deviation 26.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 32
|
1.0 Scores on a scale
Standard Deviation 27.6
|
-7.7 Scores on a scale
Standard Deviation 23.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 36
|
-2.6 Scores on a scale
Standard Deviation 24.7
|
-9.2 Scores on a scale
Standard Deviation 26.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
Week 40
|
-2.6 Scores on a scale
Standard Deviation 22.6
|
-6.7 Scores on a scale
Standard Deviation 31.5
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Constipation sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 7
|
0.3 Scores on a scale
Standard Deviation 26.4
|
2.4 Scores on a scale
Standard Deviation 26.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 16
|
5.3 Scores on a scale
Standard Deviation 22.6
|
-2.8 Scores on a scale
Standard Deviation 32.1
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 20
|
3.7 Scores on a scale
Standard Deviation 26.4
|
1.1 Scores on a scale
Standard Deviation 25.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 24
|
-0.5 Scores on a scale
Standard Deviation 23.2
|
-1.7 Scores on a scale
Standard Deviation 26.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 28
|
3.2 Scores on a scale
Standard Deviation 27.5
|
1.4 Scores on a scale
Standard Deviation 28.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 32
|
2.6 Scores on a scale
Standard Deviation 23.1
|
-5.1 Scores on a scale
Standard Deviation 27.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 36
|
3.7 Scores on a scale
Standard Deviation 23.3
|
-0.7 Scores on a scale
Standard Deviation 29.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
Week 40
|
1.1 Scores on a scale
Standard Deviation 21.6
|
0.7 Scores on a scale
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Diarrhea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 7
|
1.4 Scores on a scale
Standard Deviation 18.5
|
1.2 Scores on a scale
Standard Deviation 23.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 16
|
8.5 Scores on a scale
Standard Deviation 22.4
|
2.8 Scores on a scale
Standard Deviation 30.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 20
|
2.3 Scores on a scale
Standard Deviation 19.6
|
-1.7 Scores on a scale
Standard Deviation 22.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 24
|
1.8 Scores on a scale
Standard Deviation 17.5
|
1.1 Scores on a scale
Standard Deviation 25.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 28
|
2.8 Scores on a scale
Standard Deviation 19.2
|
0.0 Scores on a scale
Standard Deviation 19.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 32
|
0.5 Scores on a scale
Standard Deviation 19.1
|
-2.6 Scores on a scale
Standard Deviation 21.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 36
|
3.6 Scores on a scale
Standard Deviation 16.9
|
-2.0 Scores on a scale
Standard Deviation 20.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
Week 40
|
-0.5 Scores on a scale
Standard Deviation 18.4
|
-3.7 Scores on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Financial difficulties sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=118 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=109 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 7
|
2.0 Scores on a scale
Standard Deviation 24.4
|
2.4 Scores on a scale
Standard Deviation 22.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 16
|
1.1 Scores on a scale
Standard Deviation 19.8
|
4.9 Scores on a scale
Standard Deviation 21.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 20
|
2.8 Scores on a scale
Standard Deviation 20.7
|
5.3 Scores on a scale
Standard Deviation 19.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 24
|
1.8 Scores on a scale
Standard Deviation 22.8
|
5.7 Scores on a scale
Standard Deviation 17.8
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 28
|
2.8 Scores on a scale
Standard Deviation 23.6
|
6.8 Scores on a scale
Standard Deviation 22.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 32
|
2.1 Scores on a scale
Standard Deviation 22.7
|
5.8 Scores on a scale
Standard Deviation 22.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 36
|
3.6 Scores on a scale
Standard Deviation 22.3
|
8.5 Scores on a scale
Standard Deviation 18.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
Week 40
|
1.1 Scores on a scale
Standard Deviation 23.9
|
8.1 Scores on a scale
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Fatigue sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 7
|
5.1 Scores on a scale
Standard Deviation 23.3
|
11.5 Scores on a scale
Standard Deviation 23.2
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 16
|
9.2 Scores on a scale
Standard Deviation 25.8
|
5.1 Scores on a scale
Standard Deviation 24.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 20
|
4.4 Scores on a scale
Standard Deviation 20.6
|
7.9 Scores on a scale
Standard Deviation 20.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 24
|
5.4 Scores on a scale
Standard Deviation 20.5
|
6.9 Scores on a scale
Standard Deviation 24.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 28
|
4.8 Scores on a scale
Standard Deviation 22.9
|
2.1 Scores on a scale
Standard Deviation 19.5
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 32
|
5.5 Scores on a scale
Standard Deviation 23.7
|
3.2 Scores on a scale
Standard Deviation 22.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 36
|
5.4 Scores on a scale
Standard Deviation 27.1
|
1.7 Scores on a scale
Standard Deviation 21.2
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
Week 40
|
5.8 Scores on a scale
Standard Deviation 24.3
|
0.7 Scores on a scale
Standard Deviation 24.7
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Nausea and Vomiting sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points for the various scales of the EORTC QLQ-C30
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=112 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 7
|
1.5 Scores on a scale
Standard Deviation 16.4
|
4.9 Scores on a scale
Standard Deviation 18.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 16
|
-0.3 Scores on a scale
Standard Deviation 20.4
|
3.1 Scores on a scale
Standard Deviation 11.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 20
|
-2.3 Scores on a scale
Standard Deviation 10.1
|
1.1 Scores on a scale
Standard Deviation 13.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 24
|
-0.5 Scores on a scale
Standard Deviation 16.2
|
4.0 Scores on a scale
Standard Deviation 18.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 28
|
0.7 Scores on a scale
Standard Deviation 13.5
|
0.7 Scores on a scale
Standard Deviation 14.3
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 32
|
-1.3 Scores on a scale
Standard Deviation 14.2
|
0.3 Scores on a scale
Standard Deviation 15.7
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 36
|
0.0 Scores on a scale
Standard Deviation 18.5
|
1.6 Scores on a scale
Standard Deviation 16.1
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
Week 40
|
-1.3 Scores on a scale
Standard Deviation 12.1
|
0.7 Scores on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Weeks 7, 16, 20, 24, 28, 32, 36, 40Population: All treated participants in cohorts A and B
Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Pain sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=121 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=111 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 32
|
-2.8 Scores on a scale
Standard Deviation 27.1
|
-4.5 Scores on a scale
Standard Deviation 26.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 7
|
-1.7 Scores on a scale
Standard Deviation 28.0
|
1.5 Scores on a scale
Standard Deviation 25.6
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 16
|
-2.9 Scores on a scale
Standard Deviation 22.9
|
-2.8 Scores on a scale
Standard Deviation 23.4
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 20
|
-5.7 Scores on a scale
Standard Deviation 20.1
|
1.7 Scores on a scale
Standard Deviation 28.0
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 24
|
-2.9 Scores on a scale
Standard Deviation 20.9
|
0.9 Scores on a scale
Standard Deviation 31.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 28
|
-3.0 Scores on a scale
Standard Deviation 25.5
|
-3.7 Scores on a scale
Standard Deviation 30.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 36
|
-2.6 Scores on a scale
Standard Deviation 21.3
|
-2.6 Scores on a scale
Standard Deviation 29.9
|
|
Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
Week 40
|
0.3 Scores on a scale
Standard Deviation 25.3
|
-3.3 Scores on a scale
Standard Deviation 27.2
|
POST_HOC outcome
Timeframe: From first dose of study treatment to 30 days after the last dose of study treatment (up to approximately 30 months)Population: All treated participants in cohorts A and B
The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until study completion date: 28-May-2021)
Outcome measures
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 Participants
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=178 Participants
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
|---|---|---|
|
The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) - Extended Collection
|
33.9 Percentage of participants
Interval 27.0 to 41.3
|
48.3 Percentage of participants
Interval 40.8 to 55.9
|
Adverse Events
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
Serious events: 109 serious events
Other events: 169 other events
Deaths: 85 deaths
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
Serious events: 127 serious events
Other events: 172 other events
Deaths: 78 deaths
Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg
Serious events: 14 serious events
Other events: 26 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 participants at risk
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=178 participants at risk
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg
n=27 participants at risk
nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Eosinophilia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymph node pain
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Acute coronary syndrome
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina pectoris
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cardiopulmonary failure
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.4%
6/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Thyroiditis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Diplopia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Dry eye
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Keratitis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Orbital myositis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vision blurred
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.3%
6/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
10/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
5/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
12/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastritis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 necrosis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 obstruction
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
4/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest pain
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperthermia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Inflammation
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza like illness
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
5/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
11/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Systemic inflammatory response syndrome
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.8%
5/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cytolysis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
4/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
8/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cytokine release syndrome
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arthritis bacterial
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chorioretinitis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cytomegalovirus infection
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 intestinal perforated
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Endocarditis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Erysipelas
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Folliculitis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infected cyst
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymph gland infection
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningoencephalitis viral
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
5/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
4/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia bacterial
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pneumococcal
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 respiratory syncytial viral
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Spinal cord infection
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Wound infection
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hip fracture
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Overdose
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Antibiotic level below therapeutic
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatic enzyme increased
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza A virus test positive
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Transaminases increased
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
4/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bone pain
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fasciitis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Intracranial tumour haemorrhage
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.8%
23/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.6%
26/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pain
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dystonia
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epilepsy
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperaesthesia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ischaemic stroke
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Loss of consciousness
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningism
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningoradiculitis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Migraine
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Motor dysfunction
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paraesthesia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Partial seizures
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sciatica
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Seizure
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Status epilepticus
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Mania
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Autoimmune nephritis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chronic kidney disease
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Nephritis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Renal failure
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lower respiratory tract congestion
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Organising pneumonia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.9%
7/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
4/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 mass
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 sarcoidosis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Toxic skin eruption
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urticaria
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Aortic stenosis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Deep vein thrombosis
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 stenosis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 embolism
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Shock haemorrhagic
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Superior vena cava syndrome
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vasculitis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
n=180 participants at risk
nivolumab 3 mg/kg IV combined with ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks.
|
Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
n=178 participants at risk
nivolumab 1 mg/kg IV combined with ipilimumab 3 mg/kg IV every 3 weeks for 4 doses then nivolumab (flat dose 480 mg) every 4 weeks
|
Cohort C, Nivolumab 6 mg/kg + Ipilimumab 1 mg/kg
n=27 participants at risk
nivolumab 6 mg/kg plus ipilimumab 1 mg/kg followed by nivolumab 480 mg Flat Dose 4 weeks later and repeated every 8 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
20/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.6%
17/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bradycardia
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
4/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
12/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
20/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.4%
31/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
5.6%
10/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
12/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.0%
27/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.0%
41/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vision blurred
|
3.3%
6/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
9/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 distension
|
2.2%
4/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
36/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.0%
25/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
6/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.7%
12/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.0%
16/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.9%
25/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.4%
31/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
36.7%
66/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
41.0%
73/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.7%
11/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
16/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.7%
28/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
22.8%
41/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
27.5%
49/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
9/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.6%
28/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.1%
34/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
27.2%
49/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.3%
54/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.6%
8/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chills
|
6.7%
12/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
10/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
36.7%
66/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.7%
51/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
29.6%
8/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza like illness
|
7.8%
14/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.4%
15/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Mucosal inflammation
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.4%
6/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.0%
18/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
12/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.7%
39/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
26.4%
47/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
6/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cholestasis
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
4/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cytolysis
|
3.3%
6/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.4%
6/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
16/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.0%
16/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.5%
5/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
14/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
8/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
5/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.3%
13/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
12.2%
22/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.2%
36/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
6/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
16/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.9%
14/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
18/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.9%
30/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.5%
5/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.6%
10/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 cholesterol increased
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.9%
7/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.3%
6/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
12/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 lactate dehydrogenase increased
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 magnesium decreased
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 thyroid stimulating hormone decreased
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.8%
5/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 thyroid stimulating hormone increased
|
2.8%
5/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cortisol decreased
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gamma-glutamyltransferase increased
|
7.2%
13/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
8/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.4%
17/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.2%
20/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Protein total decreased
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
13.9%
25/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.3%
29/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.6%
37/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.4%
31/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.8%
5/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
15/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.6%
17/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.8%
5/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
9/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.7%
39/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.2%
36/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
6/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
14/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.9%
23/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.9%
7/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.6%
10/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
4/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.9%
7/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
12.8%
23/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.4%
15/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
15/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.0%
16/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.5%
5/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
5.0%
9/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
9/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
6/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.1%
38/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.7%
51/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Paraesthesia
|
5.0%
9/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.0%
16/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anxiety
|
3.9%
7/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.9%
7/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.3%
24/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.1%
18/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
21.1%
38/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.7%
35/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
6/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.3%
33/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.6%
26/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.7%
1/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rhinitis allergic
|
0.56%
1/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.4%
8/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
11/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Eczema
|
2.2%
4/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.8%
4/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Erythema
|
3.9%
7/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.8%
5/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intertrigo
|
1.7%
3/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.56%
1/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Night sweats
|
2.2%
4/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.4%
6/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
30.6%
55/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.7%
60/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
48.1%
13/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
23.3%
42/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.3%
54/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 erythematous
|
0.00%
0/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 macular
|
3.9%
7/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
8/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
10/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.6%
17/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.5%
5/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 papular
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.7%
3/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.1%
2/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vitiligo
|
11.7%
21/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.0%
16/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
5.0%
9/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.4%
6/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
3/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lymphoedema
|
2.8%
5/180 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.1%
2/178 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.4%
2/27 • Adverse Events and Serious Adverse Events are collected from the first dose date until the last dose date + 30 days (Up to approximately 30 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 5 years)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER