Trial Outcomes & Findings for Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (NCT NCT02872116)
NCT ID: NCT02872116
Last Updated: 2025-08-07
Results Overview
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2031 participants
Primary outcome timeframe
From the date of randomization up to the date of death, up to approximately 17 months
Results posted on
2025-08-07
Participant Flow
2031 Participants Randomized and 1991 Treated
Participant milestones
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2: Chemotherapy (XELOX or FOLFOX)
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
|
Arm 3: Nivolumab + Ipilimumab
1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
|
|---|---|---|---|
|
Pre-Treatment
STARTED
|
789
|
833
|
409
|
|
Pre-Treatment
COMPLETED
|
782
|
806
|
403
|
|
Pre-Treatment
NOT COMPLETED
|
7
|
27
|
6
|
|
Treatment
STARTED
|
782
|
806
|
403
|
|
Treatment
COMPLETED
|
623
|
653
|
319
|
|
Treatment
NOT COMPLETED
|
159
|
153
|
84
|
Reasons for withdrawal
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2: Chemotherapy (XELOX or FOLFOX)
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
|
Arm 3: Nivolumab + Ipilimumab
1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
|
|---|---|---|---|
|
Pre-Treatment
Disease Progression
|
0
|
1
|
0
|
|
Pre-Treatment
Adverse event unrelated to study drug
|
0
|
2
|
1
|
|
Pre-Treatment
Participants request to discontinue study treatment
|
0
|
2
|
0
|
|
Pre-Treatment
Participant withdrew consent
|
2
|
20
|
3
|
|
Pre-Treatment
Participant no longer meets study criteria
|
4
|
0
|
0
|
|
Pre-Treatment
Other reasons
|
1
|
2
|
2
|
|
Treatment
Death
|
121
|
94
|
68
|
|
Treatment
Lost to Follow-up
|
5
|
7
|
3
|
|
Treatment
Participant withdrew consent
|
20
|
40
|
8
|
|
Treatment
Other reasons
|
13
|
12
|
5
|
Baseline Characteristics
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=789 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2: Chemotherapy (XELOX or FOLFOX)
n=833 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
|
Arm 3: Nivolumab + Ipilimumab
n=409 Participants
1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
|
Total
n=2031 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.3 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
59.8 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
59.4 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
59.9 Years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
626 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
540 Participants
n=5 Participants
|
587 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
1405 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
186 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
510 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
556 Participants
n=5 Participants
|
570 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
1390 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization up to the date of death, up to approximately 17 monthsPopulation: All randomized participants with PD-L1 CPS ≥ 5
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=473 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=482 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
|
14.39 Months
Interval 13.11 to 16.23
|
11.10 Months
Interval 10.02 to 12.09
|
PRIMARY outcome
Timeframe: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)Population: All randomized participants with PD-L1 CPS ≥ 5
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=473 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=482 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
|
7.69 Months
Interval 7.03 to 9.17
|
6.05 Months
Interval 5.55 to 6.9
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of death, up to approximately 17 monthsPopulation: All randomized participants with available OS measurements in various subsets
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 1, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=697 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=727 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
All randomized participants
|
13.73 Months
Interval 12.42 to 14.49
|
11.63 Months
Interval 10.94 to 12.52
|
|
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with PD-LI CPS ≥ 1
|
13.80 Months
Interval 12.42 to 14.82
|
11.37 Months
Interval 10.74 to 12.25
|
|
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with PD-L1 CPS ≥ 5
|
14.39 Months
Interval 13.11 to 16.23
|
11.14 Months
Interval 10.05 to 12.12
|
|
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with PD-L1 CPS ≥ 10
|
15.01 Months
Interval 13.63 to 16.66
|
10.94 Months
Interval 9.89 to 11.96
|
SECONDARY outcome
Timeframe: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)Population: All randomized participants with available PFS measurements in various subsets
Progression free survival (PFS), defined as the time from randomization to the date of the first documented progressive disease (PD) or death due to any cause, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy by BICR per RECIST1.1 in participants with PD-L1 CPS ≥ 10, 1, or all randomized subjects. Progreessive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=614 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=598 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
All randomized participants
|
7.75 Months
Interval 7.1 to 8.57
|
6.93 Months
Interval 6.67 to 7.16
|
|
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with PD-L1 CPS ≥ 1
|
7.52 Months
Interval 7.03 to 8.51
|
6.93 Months
Interval 6.21 to 7.06
|
|
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with PD-L1 CPS ≥ 5
|
8.31 Months
Interval 7.03 to 9.4
|
6.14 Months
Interval 5.55 to 6.93
|
|
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with PD-L1 CPS ≥ 10
|
8.41 Months
Interval 7.0 to 9.79
|
5.82 Months
Interval 5.45 to 6.9
|
SECONDARY outcome
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)Population: All randomized participants in various subsets as determined by PD-L1 CPS status
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=789 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=792 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with CPS ≥ 10
|
48.8 Percentage of Participants
Interval 43.6 to 54.0
|
37.7 Percentage of Participants
Interval 32.9 to 42.7
|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with CPS ≥ 1
|
48.8 Percentage of Participants
Interval 44.9 to 52.8
|
38.0 Percentage of Participants
Interval 34.2 to 41.8
|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Participants with CPS ≥ 5
|
50.1 Percentage of Participants
Interval 45.5 to 54.7
|
38.2 Percentage of Participants
Interval 33.8 to 42.7
|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
All randomized participants
|
46.9 Percentage of Participants
Interval 43.4 to 50.4
|
37.2 Percentage of Participants
Interval 33.9 to 40.7
|
SECONDARY outcome
Timeframe: From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months)Population: All Treated participants with TTSD measurements
TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=194 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=193 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
|
NA Months
Interval 22.64 to
Median and upper limits not reached because of insufficient number of events.
|
21.03 Months
Interval 12.45 to
Upper limits not reached because of insufficient number of events.
|
SECONDARY outcome
Timeframe: From the date of randomization up to the date of death, up to approximately 14 monthsPopulation: All randomized participants with available measurements in various subsets as determined by PD-L1 CPS status
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 1, 5, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=404 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=409 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Participants with CPS ≥ 5
|
11.63 Months
Interval 10.05 to 12.71
|
11.24 Months
Interval 9.17 to 13.4
|
|
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
All randomized participants
|
11.83 Months
Interval 10.97 to 12.71
|
11.73 Months
Interval 9.56 to 13.54
|
|
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Participants with CPS ≥ 1
|
11.47 Months
Interval 10.48 to 12.65
|
11.73 Months
Interval 9.49 to 13.54
|
|
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Participants with CPS ≥ 10
|
11.33 Months
Interval 9.92 to 12.65
|
11.63 Months
Interval 9.26 to 13.54
|
SECONDARY outcome
Timeframe: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)Population: All randomized participants with available measurements in various subsets as determined by PD-L1 CPS status
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Ipilumab vs Chemotherapy with PD-L1 CPS ≥ 10, 5, 1 or all randomized participants. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=404 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=409 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
PD-L1 CPS ≥ 10
|
6.28 Months
Interval 5.52 to 7.13
|
2.89 Months
Interval 2.63 to 4.24
|
|
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
All randomized participants
|
7.06 Months
Interval 6.87 to 8.21
|
2.83 Months
Interval 2.63 to 3.58
|
|
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
PD-L1 CPS ≥ 1
|
6.93 Months
Interval 5.98 to 7.26
|
2.79 Months
Interval 2.6 to 3.91
|
|
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
PD-L1 CPS ≥ 5
|
6.28 Months
Interval 5.59 to 7.06
|
2.83 Months
Interval 2.6 to 4.04
|
SECONDARY outcome
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)Population: All randomized participants in various subsets as determined by PD-L1 CPS status
Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS ≥ 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
Outcome measures
| Measure |
Arm 1: Nivolumab + Chemotherapy (XELOX or FOLFOX)
n=404 Participants
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Arm 2a: Chemotherapy (XELOX or FOLFOX)
n=409 Participants
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. Comparison group to Arm 1.
|
|---|---|---|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
All randomized participants
|
34.9 Percentage of Participants
Interval 30.3 to 39.8
|
20.8 Percentage of Participants
Interval 17.0 to 25.0
|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Participants with CPS ≥ 1
|
37.3 Percentage of Participants
Interval 32.0 to 42.9
|
21.7 Percentage of Participants
Interval 17.4 to 26.6
|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Participants with CPS ≥ 5
|
37.7 Percentage of Participants
Interval 31.5 to 44.1
|
23.1 Percentage of Participants
Interval 17.8 to 29.0
|
|
Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Participants with CPS ≥ 10
|
35.9 Percentage of Participants
Interval 29.2 to 43.0
|
24.3 Percentage of Participants
Interval 18.3 to 31.2
|
Adverse Events
Nivo + Chemo
Serious events: 529 serious events
Other events: 763 other events
Deaths: 691 deaths
Chemo
Serious events: 474 serious events
Other events: 756 other events
Deaths: 741 deaths
Nivo + Ipi
Serious events: 307 serious events
Other events: 369 other events
Deaths: 361 deaths
Serious adverse events
| Measure |
Nivo + Chemo
n=782 participants at risk
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Chemo
n=806 participants at risk
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
|
Nivo + Ipi
n=403 participants at risk
1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
|
|---|---|---|---|
|
Cardiac disorders
Autoimmune myocarditis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
28/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.1%
17/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.2%
13/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
20/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.2%
10/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Acute coronary syndrome
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Acute myocardial infarction
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Angina pectoris
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Angina unstable
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Arrhythmia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Cardiac failure congestive
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Cardiac tamponade
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.62%
5/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Pericardial effusion
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Tachycardia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Congenital, familial and genetic disorders
Choledochal cyst
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Congenital, familial and genetic disorders
Microvillous inclusion disease
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Adrenal insufficiency
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
4/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypophysitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
4/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypopituitarism
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypothyroidism
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Cataract
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Ocular vasculitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Eye disorders
Visual impairment
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
12/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.6%
13/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
4/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Ascites
|
1.9%
15/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.1%
9/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Colitis
|
0.77%
6/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.7%
11/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Constipation
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
21/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.7%
14/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.2%
13/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
13/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.9%
23/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.2%
9/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Enteritis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Enterocolitis
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.4%
11/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
4/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastric perforation
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
13/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.1%
9/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
4/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrointestinal stenosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Haematemesis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Ileus
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.7%
11/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.87%
7/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Malabsorption
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Melaena
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Nausea
|
1.0%
8/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.2%
10/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.7%
7/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
6/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal compression
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
4/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Prepyloric stenosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.62%
5/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Stomatitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Subileus
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.2%
17/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.2%
10/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.2%
13/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
29/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.9%
23/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.7%
11/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Asthenia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.62%
5/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Catheter site extravasation
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Catheter site haemorrhage
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Oesophageal candidiasis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Chest discomfort
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Complication associated with device
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Death
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Disease progression
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Effusion
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Euthanasia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Face oedema
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Fatigue
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Gait disturbance
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
General physical health deterioration
|
0.64%
5/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.87%
7/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Generalised oedema
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Inflammation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Malaise
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Mucosal inflammation
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Non-cardiac chest pain
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Oedema peripheral
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Pain
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Performance status decreased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Peripheral swelling
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Pyrexia
|
2.8%
22/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.4%
11/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.2%
9/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Sudden death
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Bile duct stone
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholangitis
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholecystitis
|
0.64%
5/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatic cyst ruptured
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatic failure
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.2%
5/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.2%
5/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Jaundice
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.77%
6/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Jaundice extrahepatic obstructive
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Liver disorder
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Portal hypertension
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Immune system disorders
Anaphylactic reaction
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Immune system disorders
Drug hypersensitivity
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Immune system disorders
Hypersensitivity
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Abdominal abscess
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Abdominal infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Abdominal sepsis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Amoebic colitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Anal abscess
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Appendicitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Arthritis bacterial
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Bacteraemia
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Biliary tract infection
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Bronchitis
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
COVID-19 pneumonia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Cellulitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Chorioretinitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Clostridium difficile colitis
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Cystitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Dengue fever
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Device related infection
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Encephalitis
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Endocarditis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Endophthalmitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Enteritis infectious
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Enterocolitis infectious
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Epididymitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Febrile infection
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Giardiasis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Herpes virus infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Infection
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Influenza
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Large intestine infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Localised infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Lower respiratory tract infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Lung abscess
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Neutropenic sepsis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Peritonitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Peritonitis bacterial
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumonia
|
3.8%
30/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.6%
21/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.5%
14/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumonia bacterial
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumonia klebsiella
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pulmonary sepsis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Respiratory tract infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Sepsis
|
1.5%
12/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
8/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Septic shock
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Skin infection
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Soft tissue infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Staphylococcal infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Tuberculous pleurisy
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Urinary tract infection
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Urosepsis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Vascular device infection
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Viral infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.77%
6/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Overdose
|
1.4%
11/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
6/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Alanine aminotransferase increased
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Amylase increased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood bilirubin increased
|
0.77%
6/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood creatinine increased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
General physical condition abnormal
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Hepatitis C virus test positive
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Lipase increased
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Liver function test increased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Neutrophil count decreased
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Platelet count decreased
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Transaminases increased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Troponin increased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Weight decreased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.90%
7/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.1%
9/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
8/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.87%
7/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.62%
5/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
4/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
31.7%
248/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
30.5%
246/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
27.8%
112/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour obstruction
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Aphasia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Brain oedema
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Brain stem infarction
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cerebral infarction
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cerebral ischaemia
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Cerebrovascular accident
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Encephalopathy
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Epilepsy
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Headache
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Ischaemic stroke
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Neuritis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Neuropathy peripheral
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Presyncope
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Seizure
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Spinal cord compression
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Syncope
|
1.2%
9/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Device breakage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Device dislocation
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Device leakage
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Device malfunction
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Device occlusion
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Product Issues
Stent malfunction
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Depression
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Acute kidney injury
|
0.77%
6/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
4/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.2%
9/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Haematuria
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Nephritis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Prerenal failure
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Renal failure
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Renal impairment
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal effusion
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.64%
5/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
6/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.64%
5/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
19/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.7%
7/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
14/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.2%
18/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.5%
10/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.64%
5/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Surgical and medical procedures
Gastrectomy
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Surgical and medical procedures
Tumour excision
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.37%
3/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.74%
3/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Embolism
|
0.77%
6/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypotension
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypovolaemic shock
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Jugular vein thrombosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Obstructive shock
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Peripheral ischaemia
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Shock
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Subclavian artery stenosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Thrombosis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Venous thrombosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Cardiac disorders
Myocardial injury
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Malignant ascites
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
COVID-19
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Biliary cyst
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Hepatobiliary disorders
Suspected drug-induced liver injury
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.50%
2/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Haematological infection
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Pneumonia aspiration
|
0.38%
3/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Afferent loop syndrome
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Injury, poisoning and procedural complications
Vascular access malfunction
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.26%
2/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
1/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.13%
1/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.12%
1/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
Other adverse events
| Measure |
Nivo + Chemo
n=782 participants at risk
Nivolumab + Xelox: Nivolumab 360 mg IV over 30 minutes on Day 1 of each treatment cycle, every 3 weeks + Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks
Nivolumab + Folfox: Nivolumab 240 mg IV over 30 minutes on Day 1 of each treatment cycle, every 2 weeks + Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks
|
Chemo
n=806 participants at risk
Chemotherapy (XELOX or FOLFOX): Xelox: Oxaliplatin 130 mg/m2 IV on Day 1 of each treatment cycle + capecitabine 1000 mg/m2 orally twice daily (ie, 1000 mg/m2 in the morning and 1000 mg/m2 in the evening) on Days 1 to 14 of each treatment cycle, every 3 weeks. Folfox: Oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + fluorouracil 400 mg/m2 IV on Day 1 of each treatment cycle, and fluorouracil 1200 mg/m2 IV continuous infusion over 24 hours (or per local standard) daily on Days 1 and 2 of each treatment cycle, every 2 weeks. This chemotherapy group consists of the two comparison chemotherapy sub-groups. Arm 2a (792 participants) is the comparison group to Arm 1 and Arm 2b (404 participants) is the comparison group to Arm 3. Some participants were counted in both Arm 2a and Arm 2b.
|
Nivo + Ipi
n=403 participants at risk
1 mg/kg nivolumab administered IV over 30 minutes followed by ipilimumab 3 mg/kg administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses (Cycles 1 to 4), followed by nivolumab 240 mg administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks (Cycle 5 and beyond). Arm is closed to enrollment as of 05-June-2018.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.6%
67/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.8%
31/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.0%
12/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Amylase increased
|
11.6%
91/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.6%
45/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
11.9%
48/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
21.1%
165/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
14.3%
115/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
20.1%
81/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
13.7%
107/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.6%
69/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
11.7%
47/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Alanine aminotransferase increased
|
15.3%
120/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
10.9%
88/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
18.9%
76/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Anaemia
|
39.9%
312/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
34.6%
279/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
32.8%
132/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
76/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.1%
65/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.2%
9/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.3%
221/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
25.4%
205/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
4.5%
18/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.0%
172/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
20.0%
161/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.5%
10/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hyperthyroidism
|
3.8%
30/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.25%
2/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
6.5%
26/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Endocrine disorders
Hypothyroidism
|
10.5%
82/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.6%
13/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
13.4%
54/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
7.2%
56/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.3%
43/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
6.5%
26/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
20.3%
159/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
16.6%
134/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
16.4%
66/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
75/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.6%
77/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.2%
37/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Constipation
|
25.7%
201/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
22.0%
177/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
19.1%
77/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
39.6%
310/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
35.6%
287/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
27.8%
112/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Dysphagia
|
8.2%
64/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.1%
65/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.9%
32/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Nausea
|
49.4%
386/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
45.2%
364/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
25.1%
101/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Stomatitis
|
8.7%
68/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.1%
57/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.2%
13/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Gastrointestinal disorders
Vomiting
|
31.7%
248/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
29.0%
234/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
17.9%
72/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Asthenia
|
15.2%
119/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
16.1%
130/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
11.9%
48/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Fatigue
|
34.9%
273/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
29.2%
235/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
25.6%
103/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Malaise
|
5.1%
40/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.1%
41/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
4.7%
19/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Mucosal inflammation
|
9.8%
77/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.8%
47/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.7%
7/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Oedema peripheral
|
11.9%
93/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.3%
67/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
10.9%
44/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
General disorders
Pyrexia
|
18.3%
143/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
11.8%
95/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
23.1%
93/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Immune system disorders
Hypersensitivity
|
6.1%
48/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.6%
13/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.99%
4/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood bilirubin increased
|
10.6%
83/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.7%
62/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.4%
30/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Blood creatinine increased
|
5.4%
42/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.7%
22/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.7%
35/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Lipase increased
|
13.7%
107/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.9%
72/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
12.9%
52/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Neutrophil count decreased
|
21.9%
171/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
17.4%
140/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
4.7%
19/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Platelet count decreased
|
22.4%
175/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
16.4%
132/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.2%
21/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
Weight decreased
|
17.8%
139/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
15.9%
128/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
14.9%
60/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Investigations
White blood cell count decreased
|
15.9%
124/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
11.4%
92/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
4.0%
16/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.3%
237/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
28.0%
226/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
27.5%
111/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.5%
82/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.9%
64/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.2%
37/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.9%
109/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.9%
72/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
15.4%
62/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.8%
53/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
4.6%
37/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.2%
21/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.9%
93/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.2%
74/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.2%
37/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.2%
72/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
6.3%
51/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
13.2%
53/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
74/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.2%
42/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.4%
30/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
87/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.6%
69/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.4%
38/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
43/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.6%
21/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.2%
9/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Dizziness
|
7.3%
57/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.3%
59/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
4.0%
16/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Dysgeusia
|
6.1%
48/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.3%
43/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.5%
10/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Headache
|
11.4%
89/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
6.6%
53/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.2%
33/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Hypoaesthesia
|
5.8%
45/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.2%
42/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.5%
6/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Neuropathy peripheral
|
30.8%
241/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
26.2%
211/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.7%
7/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Paraesthesia
|
9.2%
72/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.7%
78/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
1.7%
7/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.7%
146/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
16.0%
129/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
3.2%
13/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Psychiatric disorders
Insomnia
|
7.8%
61/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.6%
69/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
8.9%
36/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
102/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
7.9%
64/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
12.7%
51/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.4%
66/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
6.1%
49/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
9.2%
37/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
13.8%
108/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
12.2%
98/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.00%
0/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.1%
79/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.4%
19/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
17.9%
72/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
90/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.7%
22/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
19.1%
77/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.6%
28/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
0.87%
7/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
10.2%
41/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypertension
|
6.1%
48/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.2%
42/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
4.2%
17/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
|
Vascular disorders
Hypotension
|
3.3%
26/782 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
2.6%
21/806 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
5.2%
21/403 • All-cause mortality was assessed from date of randomization to study completion (up to approximately 5 years). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 5 years).
All-Cause Mortality =all randomized participants AEs and NSAEs (Other Adverse Events) = all treated participants
|
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