Trial Outcomes & Findings for A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H) (NCT NCT03668119)
NCT ID: NCT03668119
Last Updated: 2024-08-28
Results Overview
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
212 participants
Primary outcome timeframe
From date of randomization up to 42 months
Results posted on
2024-08-28
Participant Flow
Salvage setting describes participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with Tumor Mutational Burden-High (TMB-H) who are refractory to standard therapies per local management guidelines, or for which no standard treatment per local management guidelines is available. Participants randomized to the Nivolumab monotherapy arm B were allowed to rollover to Nivolumab+Ipilimumab arm A at the time of progression.
Participant milestones
| Measure |
Arm A: Nivolumab+Ipilimumab
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Pre-treatment
STARTED
|
136
|
76
|
|
Pre-treatment
bTMB-H Started
|
80
|
45
|
|
Pre-treatment
tTMB-H Started
|
88
|
47
|
|
Pre-treatment
COMPLETED
|
135
|
76
|
|
Pre-treatment
NOT COMPLETED
|
1
|
0
|
|
Treatment
STARTED
|
135
|
76
|
|
Treatment
bTMB-H Started
|
83
|
47
|
|
Treatment
tTMB-H Started
|
94
|
50
|
|
Treatment
Arm B Rollover
|
0
|
22
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
135
|
76
|
Reasons for withdrawal
| Measure |
Arm A: Nivolumab+Ipilimumab
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Pre-treatment
Disease Progression
|
1
|
0
|
|
Treatment
Disease Progression
|
76
|
57
|
|
Treatment
Study drug toxicity
|
19
|
1
|
|
Treatment
Death
|
3
|
0
|
|
Treatment
Adverse Event unrelated to Study drug
|
4
|
3
|
|
Treatment
Withdrawal by Subject
|
1
|
1
|
|
Treatment
Participant request to discontinue study treatment
|
3
|
1
|
|
Treatment
Maximum Clinical Benefit
|
0
|
1
|
|
Treatment
Participants completed treatment
|
27
|
11
|
|
Treatment
Other reasons
|
2
|
1
|
Baseline Characteristics
A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Baseline characteristics by cohort
| Measure |
Arm A: Nivolumab+Ipilimumab
n=136 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=76 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
57.6 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
59.2 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
78 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization up to 42 monthsPopulation: All participants randomized in a salvage setting to arm A by TMB-High status
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=88 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A
Blood TMB-H (bTMB-H)
|
22.5 Precentage of participants
Interval 13.9 to 33.2
|
—
|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A
Tissue TMB-H (tTMB-H)
|
38.6 Precentage of participants
Interval 28.4 to 49.6
|
—
|
SECONDARY outcome
Timeframe: From date of randomization up to 57 monthsPopulation: All participants randomized in a salvage setting to arm B by TMB-High status
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=47 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B
Blood TMB-H (bTMB-H)
|
15.6 Percentage of participants
Interval 6.5 to 29.5
|
—
|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B
Tissue TMB-H (tTMB-H)
|
29.8 Percentage of participants
Interval 17.3 to 44.9
|
—
|
SECONDARY outcome
Timeframe: From date of randomization up to 57 monthsPopulation: All participants randomized in a salvage setting by TMB-High status
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on investigator assessment. Calculated using Clopper-Pearson method. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=88 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=47 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Objective Response Rate (ORR) Per Investigator
Blood TMB-H (bTMB-H)
|
25.0 Percentage of participants
Interval 16.0 to 35.9
|
13.3 Percentage of participants
Interval 5.1 to 26.8
|
|
Objective Response Rate (ORR) Per Investigator
Tissue TMB-H (tTMB-H)
|
44.3 Percentage of participants
Interval 33.7 to 55.3
|
23.4 Percentage of participants
Interval 12.3 to 38.0
|
SECONDARY outcome
Timeframe: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)Population: All responders (CR or PR) randomized in a salvage setting by TMB-High status
DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically. PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=39 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=11 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Duration of Response (DoR) Per Investigator
Blood TMB-H (bTMB-H)
|
27.96 Months
Interval 11.2 to
insufficient number of participants with events
|
NA Months
Interval 11.24 to
insufficient number of participants with events
|
|
Duration of Response (DoR) Per Investigator
Tissue TMB-H (tTMB-H)
|
NA Months
Interval 27.96 to
insufficient number of participants with events
|
NA Months
Interval 8.05 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)Population: All responders (CR or PR) randomized in a salvage setting by TMB-High status
DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically. PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=34 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=14 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Blood TMB-H (bTMB-H)
|
NA Months
Interval 10.15 to
insufficient number of participants with events
|
NA Months
Interval 5.52 to
insufficient number of participants with events
|
|
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Tissue TMB-H (tTMB-H)
|
NA Months
Interval 33.51 to
insufficient number of participants with events
|
NA Months
Interval 8.31 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)Population: All responders (CR or PR) randomized in a salvage setting by TMB-High status
TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on investigator assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=39 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=11 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Time to Objective Response (TTR) Per Investigator
Blood TMB-H (bTMB-H)
|
3.48 Months
Standard Deviation 1.17
|
4.08 Months
Standard Deviation 3.40
|
|
Time to Objective Response (TTR) Per Investigator
Tissue TMB-H (tTMB-H)
|
3.56 Months
Standard Deviation 1.74
|
3.75 Months
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)Population: All responders (CR or PR) randomized in a salvage setting by TMB-High status
TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=34 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=14 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
Blood TMB-H (bTMB-H)
|
3.59 Months
Standard Deviation 1.65
|
4.33 Months
Standard Deviation 2.93
|
|
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
Tissue TMB-H (tTMB-H)
|
4.37 Months
Standard Deviation 5.10
|
3.98 Months
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: From date of randomization up to 57 monthsPopulation: All participants randomized in a salvage setting by TMB-High status
CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on investigator assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD RANO Criteria: CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=88 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=47 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Clinical Benefit Rate (CBR) Per Investigator
Blood TMB-H (bTMB-H)
|
42.5 Percentage of participants
Interval 31.5 to 54.1
|
40.0 Percentage of participants
Interval 25.7 to 55.7
|
|
Clinical Benefit Rate (CBR) Per Investigator
Tissue TMB-H (tTMB-H)
|
63.6 Percentage of participants
Interval 52.7 to 73.6
|
46.8 Percentage of participants
Interval 32.1 to 61.9
|
SECONDARY outcome
Timeframe: From date of randomization up to 57 monthsPopulation: All participants randomized in a salvage setting by TMB-High status
CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) per Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= does not qualify for PR or progressive disease RANO Criteria: CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=88 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=47 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
Blood TMB-H (bTMB-H)
|
32.5 Percentage of participants
Interval 22.4 to 43.9
|
28.9 Percentage of participants
Interval 16.4 to 44.3
|
|
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
Tissue TMB-H (tTMB-H)
|
53.4 Percentage of participants
Interval 42.5 to 64.1
|
38.3 Percentage of participants
Interval 24.5 to 53.6
|
SECONDARY outcome
Timeframe: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)Population: All participants randomized in a salvage setting by TMB-High status
PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by investigator assessment, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm. RANO Criteria: PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=88 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=47 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Progression Free Survival (PFS) Per Investigator
Blood TMB-H (bTMB-H)
|
2.99 Months
Interval 2.66 to 4.34
|
3.04 Months
Interval 2.79 to 5.36
|
|
Progression Free Survival (PFS) Per Investigator
Tissue TMB-H (tTMB-H)
|
8.15 Months
Interval 4.83 to 12.94
|
3.06 Months
Interval 2.79 to 10.91
|
SECONDARY outcome
Timeframe: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)Population: All participants randomized in a salvage setting by TMB-High status
PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by Blinded Independent Central Review (BICR) assessment, or death due to any cause, whichever occurs first. Calculated using KM method. RECIST Criteria: Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm. RANO Criteria: PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=88 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=47 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Blood TMB-H (bTMB-H)
|
2.83 Months
Interval 2.33 to 2.99
|
2.83 Months
Interval 2.6 to 3.25
|
|
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Tissue TMB-H (tTMB-H)
|
5.68 Months
Interval 3.19 to 11.6
|
2.83 Months
Interval 2.69 to 5.72
|
SECONDARY outcome
Timeframe: From date of randomization to date of death (Up to 57 months)Population: All participants randomized in a salvage setting by TMB-High status
OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who did not have a date of death were censored on the last date for which a participant was known to be alive. Calculated using KM method.
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=88 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=47 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Overall Survival (OS)
Blood TMB-H (bTMB-H)
|
8.07 Months
Interval 5.82 to 10.45
|
11.24 Months
Interval 5.26 to 18.99
|
|
Overall Survival (OS)
Tissue TMB-H (tTMB-H)
|
16.48 Months
Interval 10.18 to 30.52
|
14.59 Months
Interval 7.69 to 18.23
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 25 months)Population: All treated participants by TMB-High status
Number of participants with any grade adverse events (AEs), serious adverse events (SAEs), drug-related AEs, and drug-related SAEs by Tumor Mutational Burden- High (TMB-H) status using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=94 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=50 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Blood TMB-H (bTMB-H) AEs
|
82 Participants
|
46 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tissue TMB-H (tTMB-H) AEs
|
93 Participants
|
50 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
bTMB-H SAEs
|
51 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
tTMB-H SAEs
|
46 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
bTMB-H drug-related AEs
|
64 Participants
|
29 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
tTMB-H drug-related AEs
|
78 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
bTMB-H drug-related SAEs
|
17 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
tTMB-H drug-related SAEs
|
16 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 25 months)Population: All treated participants with on-treatment laboratory measures by TMB-H status
Number of participants with grade 3-4 on-treatment laboratory parameters. Parameters include hematology, chemistry, liver function, and renal function using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. Grade 3=Severe event Grade 4=Life threatening event TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive
Outcome measures
| Measure |
Arm A: Nivolumab+Ipilimumab
n=91 Participants
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=45 Participants
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
|---|---|---|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hemoglobin grade 3
|
6 Participants
|
3 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hemoglobin grade 3
|
8 Participants
|
7 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Platelet Count grade 3-4
|
1 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Platelet Count grade 3-4
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Leukocytes grade 3- 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Leukocytes grade 3- 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Leukocytes Absolute grade 3- 4
|
2 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Leukocytes Absolute grade 3- 4
|
5 Participants
|
3 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Absolute Neutrophil grade 3- 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Absolute Neutrophil grade 3- 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Alkaline Phosphatase grade 3-4
|
2 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Alkaline Phosphatase grade 3-4
|
2 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Aspartate Aminotransferase grade 3-4
|
2 Participants
|
3 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Aspartate Aminotransferase grade 3-4
|
4 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Alanine Aminotransferase grade 3-4
|
5 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Alanine Aminotransferase grade 3-4
|
3 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Bilirubin grade 3-4
|
3 Participants
|
2 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Bilirubin grade 3-4
|
3 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Creatinine grade 3-4
|
3 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Creatinine grade 3-4
|
3 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hypernatremia grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hypernatremia grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hyponatremia grade 3-4
|
4 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hyponatremia grade 3-4
|
3 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hyperkalemia grade 3-4
|
2 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hyperkalemia grade 3-4
|
2 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hypokalemia grade 3-4
|
4 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hypokalemia grade 3-4
|
3 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hypercalcemia grade 3-4
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hypercalcemia grade 3-4
|
2 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hypocalcemia grade 3-4
|
2 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hypocalcemia grade 3-4
|
0 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hyperglycemia grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hyperglycemia grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Blood TMB-H (bTMB-H) Hypoglycemia grade 3-4
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Laboratory Parameters
Tissue TMB-H (tTMB-H) Hypoglycemia grade 3-4
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A: Nivolumab+Ipilimumab
Serious events: 90 serious events
Other events: 121 other events
Deaths: 97 deaths
Arm B: Nivolumab
Serious events: 39 serious events
Other events: 64 other events
Deaths: 42 deaths
Arm B: Nivolumab+Ipilimumab (Rollover)
Serious events: 11 serious events
Other events: 13 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Arm A: Nivolumab+Ipilimumab
n=135 participants at risk
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=76 participants at risk
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
Arm B: Nivolumab+Ipilimumab (Rollover)
n=22 participants at risk
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pericarditis malignant
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Secondary adrenocortical insufficiency
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 adhesions
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.0%
4/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
3/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Enteritis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 perforation
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
3/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
3/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Death
|
2.2%
3/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
3/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hyperpyrexia
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.7%
5/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Jaundice
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abdominal abscess
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchopulmonary aspergillosis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infection
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pelvic inflammatory disease
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Peritonitis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
2.2%
3/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Femoral neck fracture
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urinary tract injury
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urine output decreased
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Osteonecrosis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pathological fracture
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
31.9%
43/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
32.9%
25/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
31.8%
7/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Meningioma
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Brain oedema
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cognitive disorder
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Dysarthria
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Product Issues
Device occlusion
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Obstructive nephropathy
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tubulointerstitial nephritis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ureteric obstruction
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Female genital tract fistula
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Uterine fistula
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 oedema
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhage
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pelvic venous thrombosis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 |
Arm A: Nivolumab+Ipilimumab
n=135 participants at risk
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W) up to 24 months
|
Arm B: Nivolumab
n=76 participants at risk
Nivolumab Monotherapy 480 mg every 4 weeks (Q4W) up to 24 months
|
Arm B: Nivolumab+Ipilimumab (Rollover)
n=22 participants at risk
Nivolumab 240 mg every 2 weeks (Q2W) + Ipilimumab 1 mg/kg every 6 weeks (Q6W)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.7%
32/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.1%
16/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.6%
3/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.4%
6/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
5/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
15/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.3%
18/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
14.5%
11/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.0%
23/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.2%
7/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.0%
23/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.2%
10/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
37.0%
50/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.4%
14/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.6%
3/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.4%
6/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.1%
19/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
15/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
4/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.1%
19/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.2%
7/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.6%
3/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.9%
16/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.2%
10/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
30.4%
41/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
22.4%
17/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.3%
22/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
5/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.6%
21/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
13.2%
10/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
7.4%
10/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pharyngitis
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
12/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
4/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.4%
6/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.1%
19/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.5%
8/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.2%
7/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.8%
20/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.8%
12/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.6%
13/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.5%
8/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.4%
10/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.2%
7/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.1%
11/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.2%
7/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 glucose increased
|
5.2%
7/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.0%
4/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.7%
28/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.9%
8/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.2%
7/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypocalcaemia
|
5.9%
8/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.9%
12/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.1%
11/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypophosphataemia
|
3.7%
5/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.3%
1/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.3%
22/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.2%
7/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.3%
18/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
5/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.1%
11/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.5%
8/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neck pain
|
0.74%
1/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.2%
7/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
8.1%
11/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
2/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.6%
13/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.3%
4/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.9%
16/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
14.8%
20/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
5/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.6%
2/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.1%
2/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
26.7%
36/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
15/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
36.4%
8/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
18.5%
25/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.2%
7/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
5.2%
7/135 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/76 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/22 • SAEs and AEs are assessed from first dose to 100 days post last dose (Up to 27 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 57 months).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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